Adhesive support devices and methods of making and using them

ABSTRACT

Described herein are adhesive support devices, which may include adhesive medical devices. In particular, three-dimensional adhesive medical devices from a single layer of material, typically by stamping or pressing (including cold pressing) a sheet of the material to form rigid and complex 3D shapes capable of use for a variety of medical and non-medical purposes. These adhesive support devices typically also include an adhesive material allowing the device to be attached to a subject&#39;s skin and/or mounted on a surface (e.g., wall, etc.). In particular, described herein are methods of manufacturing, assembling, and using adhesive support devices.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to the following U.S.provisional patent applications: U.S. provisional patent No. 61/869,900,filed on Aug. 26, 2013, and titled “ADHESIVE MEDICAL DEVICES”; U.S.provisional patent No. 61/893,095, filed on Oct. 18, 2013, and titled“ADHESIVE MEDICAL DEVICES”; U.S. provisional patent No. 61/927,943,filed on Jan. 15, 2014, and titled “ADHESIVE MEDICAL DEVICES”; and U.S.provisional patent No. 62/026,453, titled “ADHESIVE DEVICES”, and filedon Jul. 18, 2014. Each of these patent applications is hereinincorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The apparatuses and methods described herein relate to three-dimensionaladhesive products, including adhesive support devices such as adhesivemedical devices, formed of a sheet of rigid or semi-rigid material intoa 3D shape to which an adhesive material is attached, as well as methodsof making and using these apparatuses.

BACKGROUND

Adhesive products including medical devices and household consumerproducts can be used for many purposes. For example, adhesive medicaldevices are used to treat various medical and non-medical conditions orto supplement the use of other medical and consumer devices. Theseadhesive devices include, but are not limited to, adhesive bandages,ostomy devices, catheter stabilization devices, finger splints, nasalstrips, wound therapy devices, ECG leads and drug delivery patches.

Many adhesive products including medical devices that are made throughweb converting manufacturing methods, are generally flat or planar(mostly two dimensional). For example, adhesive medical bandages may nothave significant thickness, though they consist of multiple layers ofmaterials, and typically are mostly flat. There is a need for adhesiveproducts including medical devices that are three dimensional, whichwill enable a large number of new uses for such devices, uses that arenot possible to achieve with traditional flat, planar devices. These newuses may include but are not limited to stabilization of other medicaldevices, wound care, treatment of burns, ostomy devices, application ofantibiotic or antifungals, stabilization of joints, and treatment ofother skin and nail conditions.

Fabrication of layered devices, and particularly layered medical deviceby continuous processes, such as web converting, work well for flatstructures (layers), but may not be used to create devices withthree-dimensional structures. Instead, such three dimensional (3D)structures must be separately placed/positioned, which may be expensiveand time consuming, limiting rate of production and increasingmanufacturing costs and cost of goods. Thus, there is also a need forautomated processes or methods for manufacture of layered devicesincluding 3D structures.

SUMMARY

Described herein are specific variations of adhesive support devices,accessories for adhesive support devices, methods of using adhesivesupport devices and kits including adhesive support devices. Inparticular, described herein are adhesive support devices configured asadhesive medical devices. Examples of such medical devices may includebandages carrying (e.g., pre-applied) liquid, gel, or paste medicines,bandages forming a protected chamber over a wound when applied to thepatient, and the like. The adhesive medical devices described herein maybe used for various medical, non-medical and consumer healthapplications, including OTC (over-the-counter) products that treatmedical, non-medical or cosmetic conditions and/or promote wellness orother tangible or intangible benefit. The term “medical” does notexclude devices and therapies that do not treat diagnosed medicalconditions. These adhesive medical devices are thus intended to treatany health condition. Further, adhesive medical devices may be worn by asubject to enhance or supplement some body function, to treat a medicalcondition or facilitate the use of another medical device. Otheradhesive devices described herein may be purely ornamental or designedto provide amusement (e.g., toys) or be used for fashion or aestheticpurposes. In still other cases, adhesive products may be used to hangother items (e.g., serve as hooks) or manage cords, or serve otherhousehold purposes. As described in more detail below, an adhesivedevice may be secured to any part of the user's body, and may attachedto the skin of any part of the body, including the face.

The adhesive devices described herein may be completely flexible,partially flexible, partially rigid, or completely rigid. For example,the devices described herein may include an adhesive region (e.g.,configured as a holdfast region) that is at least partially flexible andmay also include another region that serves a medical or non-medicalpurpose or function. In other embodiments, the adhesive devicesdescribed herein may have a flexible portion (such as a holdfast) andanother portion or region which is more rigid, which may help providethe intended function of the adhesive device. In other embodiments, arigid layer may extend over all or substantially all, of the adhesivedevice to provide structure to the device including the holdfast region.This rigid layer may enable the device to support other devices (such asholding a tube, catheter or other medical product or to support or hangother items (thereby serving as a hook or fastener).

In general, an adhesive support devices described herein may be securedin communication with a subject's skin. The adhesive region (e.g.,holdfast) may comprise a biocompatible adhesive and a flexible substrateconfigured to conform to the subject's skin. Materials for the holdfastmay be chosen to attach the device to the skin or other body part and/orto serve an intended therapeutic or non-therapeutic function.

As used herein, rigid or semi-rigid structures, and particular 3Dstructures forming the cover, protective cap, barrier cap, protectivecover, vacuum cap, or other formed plastic component may use similarmaterials and thickness, share similar geometries, and utilize similarmanufacturing processes including in line forming using rotary dies orstep and repeat forming processes. Any description of a material,geometry, etc. for one rigid or semi-rigid 3D structure may be used forany other rigid or semi-rigid 3D structure described herein. Forexample, draft angles, relative thicknesses or sequential formingprocesses described for a barrier cap may be applicable for the vacuumcap or securement doors (including living hinges), etc.

As used herein, rigid or semi-rigid structures, and particular 3Dstructures forming the cover, protective cap, barrier cap, protectivecover, vacuum cap, or other formed plastic component, etc. describedherein, may have a material and/or structural stiffness that is above apredetermined threshold. For example, in some variations a rigid orsemi-rigid structure is formed of a material having an elastic modulusthat is relatively high, so that the material resists deformation (e.g.,a rod or sheet of material resists deformation). For example, a materialforming a 3D structure to be included in any of the apparatuses(including systems and devices) described as a stiff or rigid materialand may be a material that has an elastic modulus (e.g., Young'smodulus) value in a range of greater than about 0.4 GPa, e.g., from 0.4to 200 GPa, such as from 0.8 to 200 GPa, for example from 1.0 to 200GPa, etc. Semi-rigid materials may have an elastic modulus (e.g.,Young's modulus) of between about 0.04 and about 4 GPa, for example.Material having a range of Young's modulus such as 0.5 GPa to 100 GPa,0.9 GPa to 100 GPa, etc., may also be preferred.

A 3D structure as described herein may also be rigid or semi-rigid basedon the structural stiffness. Stiffness is understood to refer toresistance to deformation in response to applied force, and may bedescribed in terms of force per unit length (e.g., newtons per meter orpounds per inch). Stiffness, particularly of three-dimensionalstructures may be described a deflections in a particular dimension(e.g., degree of freedom); for simplicity, stiffness (rigidity) mayrefer to stiffness in the direction(s) opposing crushing forces, of the3D structure when applied to a subject. As described herein, structuralelements may be formed into the 3D structure to increase the rigidity(stiffness) of the material, including ridges, ribs, and the like, whichmay buttress and support the structure, increasing its relativerigidity.

As examples, 3D structures may use materials with tensile strength of70-80 N/mm², notched impact strength of 60-80 Kj/m², thermal coefficientof expansion 65×10⁻⁶, maximum continuous use temperature of 125° C., anddensity 1.20 g/cm³. In other cases, materials may have a tensilestrength of 0.20-0.40 N/mm², thermal coefficient of expansion100−220×10⁻⁶, maximum continuous use temperature of 65° C. and density0.944-0.965 g/cm³. In other cases, tensile strength may be approximately9500 psi, flexural modulus of approximately 345,000 psi and acoefficient of linear thermal expansion of 3.8 in/in/° F.×10⁻⁵ thoughthese values may be increased or decreased by +/−30% depending on theexact material chosen.

The adhesive devices described herein may be composed of layers. Layereddevices (which may also be referred to as layered adhesive devices orlayered adhesive medical devices) may be completely or partiallyflexible, as previously mentioned. For example, a layered device mayinclude a pad and medicament and an adhesive holdfast layer that securesthe adhesive device in communication with the skin. The adhesiveholdfast layer may itself include a flexible substrate that includes abiocompatible adhesive.

Any of the devices described herein may also include an anatomic guide,such as a ring, a conical alignment guide, a tactile alignment guide, ora visual alignment guide, which enables or facilitates placement of thedevice on or around an anatomic site on the subject's body.

In some variations, the device may further include a support frame. Thesupport frame may be removable and/or removably attached to anotherportion of the device including the adhesive substrate, the adhesivelayer or another portion of the device including rigid portions of thedevice that may be made from plastic. For example, the support frame maysupport the device, including the holdfast region of the device, and becompletely or partially removable after the device has been applied tothe subject. In some variations, the support frame remains on the deviceafter application. The support frame may serve to make application ofthe device easier or to prevent the holdfast from unintentionallyattaching to itself, to another portion of the device or to the subject.As mentioned, any of these devices may also include a support frame. Insome variations, the support frame is a support frame layer.

Also described herein are methods of treating a subject that include thesteps of removing a protective cover or liner from a layered adhesiveholdfast of an adhesive device and placing the layered device incommunication with the subject's skin.

Also described are methods of fabricating a layered medical device,including the steps of forming an adhesive layer comprising abiocompatible adhesive and forming a rigid three dimensional layer,cutting the rigid three dimensional layer (including laser cutting) andaccurately attaching this rigid layer to the layered device.

The adhesive devices described herein may be fabricated by batch orcontinuous fabrication methods, and may include the use of webconverting to enable the production of very large volumes of product atlow cost. The layered devices described herein may be contrasted withpreviously described adhesive devices that were made by other methodsthat required more assembly time, required “pick-and-place” assembly ofinjection molded parts, or were not able to be produced at low cost.

An adhesive device may be adapted to be removably secured incommunication with a subject's skin and configured to provide amedicament (which may be a liquid, semi-liquid, paste, ointment, gel,liquid matrix, liquid/solid mix, solid, fluid or semi-fluid) to asubject's skin or nails for a sustained duration to provide a benefit tothe subject. Medicaments may include various OTC and prescriptionmedications, antibiotics, antifungals or other active ingredients.Adhesive devices that deliver antibiotics may be beneficial inpreventing bacterial infection, promoting healing or reducing scarformation. Adhesive devices that deliver antifungals may be used totreat toenail fungus or other fungal skin conditions. Other adhesivedevices described herein deliver medicaments that may deliver tar (forexample to treat psoriasis), petroleum jelly, moisturizers, oils,extracts, minerals or vitamins to the skin or nails (e.g., to make themstronger, healthier or to improve appearance), and may include otheractive ingredients as described herein. The medicament may comprise anodorant, such as a fragrance. In some versions, the active agentcomprises menthol, eucalyptus oil, and/or phenol. Such devices may beapplicability in treating humans and in some cases may have veterinaryapplications for the treatment of cats, dogs, horses, alpacas and thelike.

In some cases, a protective cap is removably attached to the holdfast(and more specifically at least partly attached to the adhesive layer ofthe holdfast) which serves to protect and/or seal a medicament prior touse by the subject. This protective cap is generally a rigid orsemi-rigid three dimensional structure that has been optimized for thepurpose of protecting the medicament. As such the protective capprovides a physical barrier that may prevent or minimize migration ormovement of the medicament off the pad, especially during storage andtransport. This protective cap may serve to reduce evaporation ofcomponents of the medicament, thereby maintaining the medicament in amore preferred liquid or fluid state. In other cases, the protective capmay have one or more holes, which may enable evaporation therebyhardening or making more solid the medicament on the pad of the adhesivemedical device. The protective cap (or cover, barrier cap, protectivecover, vacuum cap, etc.) may also include a selectively compressibleregion that can be activated by applying force (e.g., from a hand orfinger) to deform the region. Such elements may be bistable, so thatdeformation of this activatable region may be achieved by applying forceabove some threshold to “snap” the structure from a first configurationto a second configuration. Bistable sub-structures may be useful forprotecting, then delivering upon user activation, a medicament asillustrated and described below.

In some cases, a barrier cap is removably attached to the holdfast (andmore specifically at least partly attached to the adhesive layer of theholdfast) and serves to protect the wound or other treatment site of thesubject. This barrier cap is generally a rigid or semi-rigid threedimensional structure that has been optimized for the purpose ofprotecting a wound. The barrier cap may also contain a medicament and/orgauze or foam or another hemostatic agent.

In some devices, the shape of the adhesive holdfast may be optimized tocomfortably fit an anatomic body site, such as parts of the face, hands,wrists, fingers, legs, ankles, toes, toe or finger nails, ostomy sites,breast, ear, earlobe, arm, chest, thorax, pelvis and the like. In somecases, the adhesive holdfast is designed to be sufficiently flexible toenable comfortable movement of the user, especially when the adhesivedevice is located on or close to a joint. In other cases, the device maybe used to stabilize a joint or prevent motion of a joint.

In other cases, the adhesive device is designed to help support thefunction of another body part or another medical device, includingintravenous (IV) catheters, peripherally inserted central catheters(PICC) or central venous catheters (CVC), urinary catheters, other typesof catheters, endotracheal tubes, nasogastic/orogastric tubes, activitymonitors as a few examples. For example, an adhesive medical device thatcomprises an adhesive holdfast that surrounds and securely andreleaseably attaches to a portion of an IV catheter may providestabilization of the IV catheter, preventing its motion which is a cancause pain or injury to the vein. A similar design can used to stabilizeurinary catheters or PICC/CVC lines, in which an adhesive holdfast isattached to a more rigid, plastic structure on the adhesive medicaldevice which removeably attaches to and secures an indwelling catheter.In other cases, the adhesive medical device may be useful in themanagement of stoma sites. For example, ostomy devices with integrated,rigid or semi-rigid rings that are fixed on an adhesive substrate (suchas a hydrocolloid) may find use. In this case, the ostomy device (orostomy “wafer”) may be attached to an ostomy or urostomy bag.

Additionally, adhesive devices are described in which the patient istreated with negative pressure wound therapy, in which an adhesiveholdfast creates a seal against the subject's skin and a chamberprovides negative pressure to the subject's wound to promote more rapidhealing. The negative pressure within the chamber may be created by oneor more of several means including patient actuation of a small vacuumchamber or by an external bulb or similar device that creates negativepressure and is attached to a tube. A negative pressure wound therapydevice and methods of manufacturing and using said device are describedand illustrated herein. The device may include a wound dressing, aplastic cover including an integrated adapter, tubing, and a vacuumsource.

As mentioned, an adhesive holdfast may include a flexible adhesivesubstrate, and/or a protective cover or liner (configured to be removed,for example, by peeling off to expose the adhesive of the adhesivelayer). The device may also include a tab or handle configured to begrasped by a subject applying the device. In some variations, this tabor handle is formed from a region of the layered adhesive holdfast.

The various components of the device may be made of any appropriatematerials, as described in greater detail below. For example, variouscomponents of the device (e.g., protective or barrier cap regions) maybe made of medical grade plastic, such as Acrylonitrile ButadieneStyrene (ABS), polypropylene, polyethylene, polycarbonate, polyurethaneor polyetheretherketone. The adhesive holdfast may include an adhesivesubstrate made of silicone, polyurethane or polyethylene. Examples ofbiocompatible adhesive on the adhesive holdfast may includehydrocolloids, hydrogels or acrylics.

Also described herein are methods of making any of the adhesive supportdevices described herein. For example, described herein are methods ofmaking an adhesive support device having a three-dimensional shape, themethod comprising: placing a planar sheet of material between a firsttool and a second tool, wherein the sheet of material extends in a firstplane and wherein the material has an elastic modulus of greater than0.4 GPa; stamping the planar sheet of material between the first tooland the second tool to deform a portion of the material so that it formsa cavity portion extending out of the first plane that is surrounded bya base region extending in the first plane; and securing an adhesivesubstrate to at least a portion of the base region.

Any of the methods of making an adhesive support device having athree-dimensional shape may include: placing a planar sheet of materialbetween a first tool and a second tool, wherein the sheet of materialextends in a first plane and wherein the material has an elastic modulusof greater than 0.4 GPa; stamping the planar sheet of material betweenthe first tool and the second tool to deform a portion of the materialso that it forms a cavity portion extending out of the first plane,wherein a wall of the cavity portion comprises one or more ridgesincreasing the rigidity of the cavity portion; and securing an adhesivesubstrate to a base region extending in the first plane wherein the baseregion is a portion of the planar sheet peripheral to the cavityportion.

For example, a method of making an adhesive support device having athree-dimensional shape, the method comprising: placing a planar sheetof material between a first tool and a second tool, wherein the sheet ofmaterial extends in a first plane, wherein the material has an initialthickness, and wherein the material has an elastic modulus of greaterthan 0.4 GPa; stamping the planar sheet of material between the firsttool and the second tool to deform a portion of the material so that itforms a cavity portion extending out of the first plane that issurrounded by a base region extending in the first plane, wherein aratio of a maximum length of the cavity portion in the first plane to amaximum depth of the cavity portion out of first plane is greater than2:1, further wherein a wall thickness of the cavity portion is less thanthe initial thickness while the thickness of the base region isapproximately the same as the initial thickness; and securing anadhesive substrate to at least a portion of the base region.

Securing an adhesive substrate to at least a portion of the base regionmay comprise securing the adhesive substrate so that the adhesivesubstrate is covered on a face opposite from the base region by a liner.

Because of the manner in which the devices described herein arefabricated, e.g., by stamping, pressing, cold pressing, etc. aninitially flat piece of rigid or semi-rigid material into a 3D shape,any of the structures described may have structural features that arecharacteristic of this formation process; these features may havefunctional benefits. For example, a wall thickness of the cavity portionmay generally be less than an initial thickness of the planar sheet ofmaterial, while the thickness of the base region may be approximatelythe same as the initial thickness. Similarly, a ratio of a maximumlength of the cavity portion in the first plane to a maximum depth ofthe cavity portion out of first plane may be greater than 2:1 (e.g., thedepth may be much less than the length).

In general, a wall of the cavity portion may comprise one or more ridgesincreasing the rigidity of the cavity portion.

The angles of all walls of the cavity portion relative to adjacentportions of the base region extending in the first plane may be greaterthan 90° and less than 180°. This angle (e.g., non-normal) wall, may beuseful for cutting, particularly when cutting the device from above(perpendicular to the plane of the base region). For example, the methodof forming may include laser cutting one or more walls of the cavityportion using a laser that is oriented perpendicular to the first plane.In general, the method may include cutting around the base region torelease the adhesive support device from the planar sheet of material.

Multiple stamping/forming steps may be performed as part of theformation. For example, the method may include stamping the planar sheetof material between a third tool and a fourth tool to further deform thecavity portion so that it extends further out of the first plane.

As mentioned above, in general, the method of forming any of thesedevice may be performed with the tool at room temperature (e.g., “cold”stamping).

Stamping the planar sheet of material between the first tool and thesecond tool may comprise compressing the planar sheet of materialbetween complementary sides of a die, wherein the first tool forms anupper side of the die and the second tool forms lower side of the die.

In any of the variations described herein, any of the stampedprojections formed in the material may then be flattened (e.g.,flattening the cavity region) which may increase support and reduce thedevice profile.

Stamping a material (having the appropriate Young's modulus) maycomprise forming a cavity region having a lattice pattern extending inparallel to the first plane; the lattice may enhance stiffness. Thematerial may have a Young's modulus of great than 0.4 GPa, greater than0.5 GPa, greater than 0.6 GPa, greater than 0.7 GPa, greater than 0.8GPa, greater than 0.9 GPa, greater than 1.0 GPa, between 0.4 GPa and 100GPa, between 0.4 GPa and 80 GPa, etc. Exemplary materials that may beused generally include a polycarbonate material (having a Young'smodulus/modulus of elasticity of between about 2.0-2.6 GPa), apolyethylene material (having a Young's modulus/modulus of elasticity ofbetween about 0.11-1 GPa, e.g., approximately 0.11 to 0.45 GPa for lowdensity polyethylene, about 0.7-1.0 GPa for high-density polyethylene),or a polyethylene terephthalate material (having a Young'smodulus/modulus of elasticity of between about 2-2.7 GPa). In general,the Young's modulus can be used to predict the elongation or compressionof an object as long as the stress is less than the yield strength ofthe material.

In general, placing comprises placing the planar sheet betweenprojecting surfaces of the first and second tool that have only roundededges. This may also result in device having projecting regions (e.g.,cavity regions, hub regions, etc.) having rounded edges on allprojecting surfaces.

Stamping the planar sheet of material between the first tool and thesecond tool to deform the material may comprise stamping an elongatehinge region in the material, and further comprising forming a livinghinge by folding the material along the elongate hinge region.

In forming the devices, one or more regions may be cut (e.g., die cut,laser cut, etc.). For example the methods may include die cutting one ormore openings through the material.

The material of the initial sheet may comprise a polycarbonate, apolyethylene, or polyethylene terephthalate.

For example, described herein are adhesive support devices having athree-dimensional shape, the device comprising: a body portioncomprising a sheet of material, the material having an elastic modulusof greater than 0.4 GPa, wherein the sheet has been deformed from a flatplane to form: a base region extending in the flat plane, the baseregion having a first thickness; and a cavity region having a thicknessthat is less than the first thickness, the cavity region at leastpartially surrounded by the base region, wherein the cavity regionextends out of the flat plane at an angle that is greater than 90°relative to an adjacent base region; and an adhesive substrate portioncoupled to at least a portion of the base region, wherein the adhesivesubstrate comprises a liner on a face opposite from the base region.

An adhesive support device having a three-dimensional shape may include:a body portion comprising a sheet of material, the material having anelastic modulus of greater than 0.4 GPa, wherein the sheet has beendeformed from a flat plane to form: a base region extending in the flatplane, the base region having a first thickness; and a cavity regionhaving a thickness that is less than the first thickness, the cavityregion at least partially surrounded by the base region, wherein thecavity region extends out of the flat plane, wherein a volume ofmaterial in any section of a continuous portion of the base regionbounded by an arbitrary shape projected from a plane that is parallel tothe flat plane is approximately equal to a volume of material in anysection of a continuous portion of the cavity region bounded by thearbitrary shape projected from the plane that is parallel to the flatpane; and an adhesive substrate portion coupled to at least a portion ofthe base region.

An adhesive support device having a three-dimensional shape may include:a body portion comprising a sheet of material, the material having anelastic modulus of greater than 0.4 GPa, wherein the sheet has beendeformed from a flat plane to form: a base region extending in the flatplane, the base region having a first thickness, a cavity region atleast partially surrounded by the base region, wherein the cavity regionextends out of the flat plane, and one or more ridges in a wall of thecavity region increasing the rigidity of the cavity portion, wherein thevolume of material in any section of a continuous portion of the baseregion bounded by a shape projected from a plane that is parallel to theflat plane is approximately equal to the volume of material in anysection of a continuous portion of the cavity region bounded by theshape projected from the plane that is parallel to the flat pane; and anadhesive substrate portion coupled to at least a portion of the baseregion, wherein the adhesive substrate comprises a liner on a faceopposite from the base region.

In general, because of the manner in which the devices described hereinare formed (e.g., by cold pressing) any of these device may includedifferent regions, such as the base region and the cavity region (or hubregion), and the volume of material in any section of a continuousportion of the base region bounded by a shape projected from a planethat is parallel to the flat plane is approximately equal to the volumeof material in any section of a continuous portion of the cavity regionbounded by the shape projected from the plane that is parallel to theflat pane. This is illustrated in FIG. 72. In this example, a sectionthrough a device 7200 formed as described herein is shown. A projectionof an arbitrary shape 7202 is made up from a plane parallel to the planeof the base region. The volume of material contained within the portionof the base region enclosed within the projected shape is shown 7210 inthis cross-section as a darker region. This volume of material isequivalent to the volume of material 7212 within a portion of non-base(e.g., a cavity region or hub region) region that is contained within anon-base portion enclosed by same projected shape 7205, when it isprojected up from the same plane.

As mentioned, any of these devices may include one or more ridges in awall of the cavity region increasing the rigidity of the cavity region.The devices may include one or more cut-out sections on a wall of thecavity region, wherein the wall is angled greater than 90° relative toan adjacent base region.

A ratio of a maximum length of the cavity portion in the flat plane to amaximum depth of the cavity portion perpendicular to the flat plane isgreater than 1:1 (e.g., 2:1, 3:1, 4:1, etc.). The angle of all walls ofthe cavity portion relative to the first plane are greater than 90° andless than 180° relative to an adjacent base region. The base region mayform a lip of greater than 0.5 mm around the cavity portion. The cavityregion may comprise a lattice pattern extending in parallel to the firstplane to enhance stiffness. As mentioned, in general, all projectingsurfaces of the cavity region have rounded edges.

Any of these devices may include an elongate hinge region in thematerial, forming a living hinge by folding the material along theelongate hinge region.

In general, the cavity (or hub) region may extend up from the baseregion by between about 1 mm and about 50 mm.

Any 3D structure may be formed of any appropriate thin layer (sheet) ormaterial having the requisite Young's modulus as described herein. Forexample, the material may comprise a polycarbonate, a polyethylene, apolyethylene terephthalate, etc.

An example of a device as described herein configured as a medicaldevice is an intraosseus needle securement device stamped from a sheetof material into a three-dimensional shape. In this example, the devicemay include: a body portion comprising a sheet of material having anelastic modulus of greater than 0.4 GPa, wherein the sheet has beenstamped from a flat plane to form: a base region extending in the flatplane, the base region having a first thickness, and a hub regionsurrounded by the base region, the hub region having a maximum wallthickness that is equal to or less than the first thickness, wherein thehub region extends from the flat plane at an angle that is greater than90° relative to an adjacent base region, the hub region having anopening configured to secure an intraosseus needle, and a plurality ofridges in the hub region extending from the base region towards theopening and configured to increase stability of the hub relative to thebase region; and an adhesive substrate coupled to the base region andconfigured to secure the device to a patient's skin.

For example, an intraosseus needle securement device stamped from asheet of material into a three-dimensional shape may include: a bodyportion comprising a sheet of material having an elastic modulus ofgreater than 0.4 GPa, wherein the sheet has been stamped from a flatplane to form: a base region extending in the flat plane, the baseregion having a first thickness, and a hub region surrounded by the baseregion, the hub region having a maximum wall thickness that is equal toor less than the first thickness, wherein each wall of the hub regionextend up from the flat plane at an angle that is greater than 90°relative to a nearest portion of the base region, the hub region havinga central opening configured to secure an intraosseus needle, and aplurality of ridges in the hub region extending up toward the openingand configured to increase stability of the hub relative to the baseregion; and an adhesive substrate coupled to the base region andconfigured to secure the device to a patient's skin.

As mentioned above, the base region comprises a raised pattern extendingin parallel to the first plane to enhance stiffness. The hub region maycomprise a generally cylindrical shape (e.g., a cylinder with an outerwall that slopes or tapers slightly inward (forming a flattened cone orbullet shape, for example).

In general, the device described are adhesive devices. These devices maygenerally include a flat (planar) region having a back side to which theadhesive material is attached. The opposite (e.g., front) side of thedevice typically includes a three-dimensional structure stamped from aplanar sheet of material so that the 3D structure extends out from thefront side.

As mentioned above, the volume of material in any section of acontinuous portion of the base region bounded by a shape projected froma plane that is parallel to the flat plane is approximately equal to thevolume of material in any section of a continuous portion of the hubregion bounded by the shape projected from the plane that is parallel tothe flat pane.

The ratio of a maximum length of the hub portion in the flat plane to amaximum depth of the hub portion perpendicular to the flat plane isgreater than 1:1.

The base region may form a lip of greater than 0.5 mm adjacent to thehub portion.

All surfaces of the hub region projecting from the flat plane may haverounded edges. The hub region may extend up from the base region bybetween about 1 mm and about 50 mm.

In general, the hub region may be continuous with the base region, or itmay be separated from the base region by one or more intermediateregions.

As mentioned above, the material forming the base and hub region (fromthe initially planar sheet) may comprise a polycarbonate, apolyethylene, or polyethylene terephthalate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one variation of an adhesive medical device with aprotective cap in an exploded view.

FIG. 2 is a different variation of the adhesive medical device shown inFIG. 1.

FIGS. 3A and 3B are different variations of the adhesive medical deviceshown in FIG. 1.

FIGS. 4A-4D are other variations of the adhesive medical device shown inFIG. 1.

FIG. 4E is an adhesive medical device with a protective cap.

FIGS. 4F-4H are top down views of alternate designs of protective caps.

FIGS. 4I-4K are cross sectional views of protective caps.

FIGS. 4L and 4M are exploded views of adhesive medical devices withprotective caps.

FIGS. 5 and 6 are cross-sectional views of the adhesive medical deviceshown in FIG. 1.

FIG. 7 is a cross-sectional view of the adhesive medical device prior toapplication onto the user.

FIG. 8 is a different variation of the adhesive medical device shown inFIG. 7.

FIGS. 9A and 9B illustrate top down and exploded view, respectively, ofan adhesive medical device.

FIGS. 9C and 9D illustrate cross sectional views of the adhesive medicaldevice shown in FIGS. 9A and 9B.

FIGS. 9E and 9F are variants of the devices shown in FIGS. 9A and 9B.

FIG. 9G is an illustration of a surgical wound.

FIG. 9H is an illustration of a medical device that has been applied tothe wound.

FIGS. 9I-9R are various adhesive medical devices with barrier caps.

FIGS. 9S and 9T are adhesive medical devices with protective features.

FIGS. 9U and 9V illustrate various shapes and sizes of protective capsfor adhesive medical devices.

FIGS. 9W and 9X illustrate devices with caps that include windows.

FIG. 10A shows different shape variations for adhesive medical devices.

FIG. 10B shows different shape variations for adhesive medical devicesfor application to the face.

FIG. 11 is a different variation of an adhesive medical device that canbe applied to the toes or fingers.

FIG. 12 is a variation of the adhesive medical device shown in FIG. 11.

FIG. 13 is another variation of the adhesive medical device shown inFIG. 11.

FIG. 14 shows the adhesive medical device shown in FIG. 11 prior toapplication onto a user.

FIG. 15 shows the adhesive medical device shown in FIG. 11.

FIG. 16 illustrates the adhesive medical device of FIG. 11 afterapplication to a user.

FIG. 17 shows another adhesive medical device that protects wires on auser.

FIGS. 18A and 18B show cross-section views of another adhesive medicaldevice designed to create negative pressure wound therapy.

FIGS. 18C and 18D illustrate a negative pressure wound therapy system.

FIG. 18E shows the pressure profile of a manually actuated vacuumsource.

FIGS. 18F-18L illustrate various views of a dressing that may be usedfor negative pressure wound therapy.

FIGS. 18M-18Q show the dressing and tubing of a negative pressure woundtherapy device and a small device that may help stabilize the tube.

FIGS. 18R-18U show top (18R) and side perspective views (18S-18U) ofanother variation of a tubing holder.

FIGS. 18V-18X illustrate another variation of a tubing holder.

FIG. 18Y shows one variation of a plastic cap.

FIG. 18Z illustrates a method of forming a plastic cap.

FIGS. 19A and 20 illustrate an adhesive medical devices designed tostabilize an IV catheter.

FIGS. 21A and 21B illustrate cross-sectional views of variants of themedical device of FIG. 20.

FIG. 21C illustrates cross-sectional views of another adhesive medicaldevice designed to stabilize an IV catheter.

FIG. 21D illustrates top down view of the adhesive medical device shownin FIG. 21C.

FIGS. 21E-21J illustrate various adhesive medical devices that aredesigned to stabilize IV catheters.

FIGS. 21K and 21L illustrate an IV stabilization device.

FIGS. 21M-21P show another embodiment of a IV securement device

FIG. 22 shows an adhesive medical device designed to stabilize a urinarycatheter.

FIG. 23 shows a cross-sectional view of the medical device in FIG. 22after application to the subject.

FIG. 24A illustrates a nasal dilator strip applied to the subject'snose.

FIGS. 24B and 24C show sectional views of the device shown FIG. 24A.

FIG. 24D shows a side view of a splint device such as the one shown inFIG. 24A.

FIGS. 24E-24G show side perspective views of different variations ofsplint devices such as the one shown in FIG. 24A.

FIGS. 24H-24J illustrate the application of a splint device such as theone shown in FIG. 24E applied to a subject's nose.

FIG. 24K shows side perspective views of various nasal splint devices.

FIGS. 24L-24S illustrate variations of nasal splint devices as describedherein.

FIGS. 25A and 25B show side and top views of an adhesive device tosplint a subject's finger.

FIG. 26A illustrates the placement of an intraosseous access device intothe bone.

FIB. 26B illustrates the top view of an intraosseous access device beingstabilized by an adhesive medical device.

FIG. 26C illustrates the side view of the device of FIG. 26B.

FIGS. 27A and 27B are various ridge or rib designs that offer increasedstability to any plastic cone design of any product described herein.

FIGS. 28A-28G illustrate a series of novel ostomy products, including anostomy wafer that snaps onto an ostomy bag.

FIGS. 29A-29C illustrate top, side and top views, respectively, of aPICC line securement device.

FIGS. 29D-29E show another variation of a PICC line guide device. FIG.29F illustrates a PICC securement device.

FIGS. 29G and 29H illustrate the formation of a snap region from a sheetof material using laser cutting.

FIG. 30 illustrates the web-converting and packaging process that wouldbe used to make any product with a 3D features attached to the adhesiveholdfast.

FIG. 31A shows a view of an IV securement device featuring a livinghinge. FIG. 31B shows an exploded view of the device shown in FIG. 31A.

FIGS. 31C-31F show additional views of an IV securement device.

FIG. 32A illustrates a top down view of PICC securement device. FIG. 32Bshows an exploded view of the device shown in 32A.

FIG. 32C illustrates a relatively rigid portion of a PICC device.

FIGS. 32D and 32E provide additional views of the PICC securement deviceshown in FIG. 32A.

FIGS. 32F-32K illustrate a PICC securement device with a living hinge.

FIG. 33A shows an example of warping of plastic that can occur duringthe forming process. FIGS. 33B and 33C show lattice structures that canminimize warping.

FIG. 33 D shows a multi-step process that can minimize warping.

FIG. 34 illustrates various radii of curvatures for shapes createdduring the forming process.

FIGS. 35A and 35B show the multi-step process of forming a 3D shape.FIG. 35C shows various shapes that have been formed to various depths.

FIGS. 36A-F illustrate different designs of living hinges that can beused in the subject devices.

FIGS. 37A-O illustrate different designs of snap hooks that can be usedin the subject devices.

FIGS. 38A-D show devices that secure a catheter and creates a loop ofcatheter within the device.

FIGS. 39, 40 and 41 illustrate devices that can be secure a tube orcatheter having one of many thicknesses.

FIGS. 42A-D shows securement devices of activity monitors.

FIGS. 43 and 44 illustrate a urinary catheter securement devicefeaturing a living hinge mechanism.

FIGS. 45A-45F illustrate hooks that can be used to secure householditems.

FIGS. 46A and 46B illustrate hooks that can be used to secure householdor medical items.

FIG. 46C, FIGS. 47-51 and FIGS. 52A and 52B each show a cord managementdevice.

FIGS. 53A and 53B illustrates a household mini-storage device.

FIG. 54 shows a hook device.

FIGS. 55 and 56 show hook devices with living hinge mechanisms.

FIGS. 57 and 58 illustrate cable securement devices with living hingemechanisms.

FIG. 59 shows a mini-storage device with a living hinge mechanism.

FIGS. 60A and 60B show hook devices.

FIGS. 61, 62, 63-65 show simple devices capable of holding objects.

FIGS. 66 and 67 illustrates a simple holder of household items such asbusiness cards and souvenirs.

FIG. 68 shows devices that can mount a photograph or other graphicmaterials.

FIG. 69 illustrates a nasogastric tube holder.

FIG. 70 shows an endotracheal tube holder.

FIG. 71 illustrates an adhesive removal device.

FIG. 72 illustrates volumes of material in section of different regionsof an exemplary device formed as described herein.

DETAILED DESCRIPTION

Described herein are devices and household products, including adhesivemedical devices having a three-dimensional structure configured to beadhesively secured to a patient or other object. Although thisdisclosure describes various different structures, any of which may bereferred to as an adhesive device, any of these devices or variations ofdevices may incorporate any of the features or elements described in anyof the other device or variations of devices. Features and elementsillustrated and described for the various figures and exemplaryembodiments described herein may, unless the context indicatesotherwise, be applied to any of the embodiments described.

For example, any of the devices described herein may be layered adhesivedevices that include a three-dimensional structure extending from anadhesive base (or substrate) that may be attached to a patient or othersurface. The three-dimensional structure may generally be formed of alightweight, relatively durable material. In any of the embodimentsdescribed herein, the structure may be formed by a press, e.g., as partof a web converting process. The 3D structure or component may be formedfrom an initially planar material (e.g., a thin polymeric material) thatis pressed (e.g., cold pressed, hot pressed, stamped, etc.) one or moretimes (sequentially) during fabrication and concurrent assembly. Thus,the resulting structure may include features that reflect this formingtechnique, such as the thickness, dimensions, orientation, vertical wallangle, and the like, as described in greater detail below. For example,the 3D structures may include an outer edge having a wall thickness thatis greater than the thickness of any of the more radially inward walls.This outer edge wall thickness may also provide improved stability andstrength.

The structures described herein may also include one or more cutting,and particularly laser cutting, steps to be formed. As described ingreater detail below, a laser cutter may be used and mounted above themanufacturing line to cut materials, including the 3D structures formedby the pressing/stamping techniques described above, including makingcut outs. Thus, in general, when laser cutting is performed, the wallsto be cut may all have outwardly sloping walls, so that the laser cutterwill be able to project its beam on the wall to be cut. A verticallyoriented laser cutter may typically emit a beam that is parallel to thevertical wall, hence for precise cutting, the wall should be sloping.For example, the walls to be cut may be sloping relative to a directionthat is perpendicular from a base region, at an angle of (relative to anouter ‘flat’ base region) greater than 90° and less than 180° (e.g.,greater than 91°, 92°, 93°, 94°, 95°, 96°, 97°, 98°, 99°, 100°, 101°,102°, 103°, 104°, 105°, 110°, 115°, etc.).

An adhesive device is one variation of a medical device in which anadhesive holdfast region is used to secure the device in communicationwith a body part of the subject such as the skin. The devices andmethods described herein are not limited to the particular embodimentsdescribed. Variations of the particular embodiments described may bemade and still fall within the scope of the disclosure. Examples andparticular embodiments described are not intended to be limiting.

Layered devices are of particular interest, and are described more fullybelow. Layered adhesive medical devices may include two or more layers.For example, a layered medical device may include an adhesive holdfastlayer (which itself is made from a single or multiple layers) and afunctional component (which may include a three dimensional rigid orsemi-rigid structure). These various layers may be composed of separatelayers, and these layers may be separated by other layers, or they maybe adjacent. The adhesive holdfast layer may be itself formed of layers(optionally: a substrate layer, a protective covering layer (or liner),an adhesive layer, etc.), and thus may be referred to as a layeredadhesive holdfast. Similarly, the functional component may be formed ofmultiple layers including layer(s) that may be rigid and be comprised ofthin plastic, for example. In some variations, the layered adhesiveholdfast and the functional component may have one or more layers. Forexample, the liner layer and protective cap may be the same layer.

As used herein, a “layer” may be generally planar geometry (e.g., flat),although it may have a thickness, which may be uniform or non-uniform insection.

The following descriptions including various design parameters or goals,and methods and devices which fit the design parameters or goals. Thedevices and methods described herein (and recited by any claims) are notlimited to any particular theory of operation.

In general, the adhesive medical devices described herein include aholdfast region (or layer) and at least one functional layer thatprovides a therapeutic or non-therapeutic function. As will be apparentfrom the figures, many of these devices may be removable and insertableby a user without special tools. In some variations, a subject may usean applicator to apply the device (e.g., to help align it). Adhesivemedical devices may also be packaged in various ways, including pouchesor boxes that may be designed to create a seal around each device oraround more than one device. In some cases, the packaging will beairtight to prevent evaporation of any parts of the device (includingthe medicament). In other cases, the packaging may not be airtight ormay be partly or completely permeable to air or gaseous components.

It may also be beneficial for a subject to wear an adhesive device overan extended period of time (several minutes to an hour to several hours,for approximately 4, 6, 8 or 12 hours, a day or more than one day,several days or a week). Some devices may be reused while others aresingle use and disposable. A user may be required to wear the device (ormultiple new devices) over the course of days, week, months or yearsdepending on the condition being treated.

Described below are variations of adhesive devices that may becomfortably worn by the subject. In some variations, a grip (e.g., atab, handle, strap, or other additional interface region) may beincluded to help secure the device to the subject's face or body, andmay additionally or alternatively be helpful in positioning ormanipulating (e.g., gripping) the device, particularly when it is beingapplied. This additional interface region may be formed of the samematerial as the adhesive holdfast region, or it may be a separateregion, as described in more detail below.

Other materials of interest include any materials that can serve asfilters. This filter may be part of the device. Any suitable filteringmaterial known to those skilled in the art may be used. Such materialsinclude, but are not limited to, activated carbon charcoal filters,hollow-fiber filters, and the like.

Adhesive Holdfast

The adhesive devices described herein generally include an adhesiveholdfast for securing the device in communication with a subject's bodyor in communication with another surface such as a wall or furniture.The adhesive holdfast may include one or more adhesive surfaces that aresuitable for use against a subject's body (e.g., skin, mucous membranes,wounds). Thus, the adhesive holdfast may include a biocompatibleadhesive. The adhesive holdfast may facilitate the positioning andsecuring of the device in a desired location with respect to thesubject's body. In some cases, the adhesive device may be removable andworn again, depending on the choice of adhesive layer (which may includesilicone for example).

The adhesive holdfast may be flexible so that it conforms to the surfaceof the subject's skin, which may be relatively irregularly shaped andmay include hair, wounds and the like. In some variations, the adhesiveholdfast is made of a material that permits the passage of water vapor,liquid water, sweat and/or oil, which may enhance comfort. In othervariations, the adhesive holdfast (and the entire device) may becompletely, mostly or somewhat occlusive, or impermeable to thesesubstances, in order to provide a moist healing environment for thewound. A fully occlusive material may help promote transport of themedicament into the skin. Any commonly used occlusive wound materialsmay be used as a component of the adhesive medical device. The adhesiveholdfast may also include a texture or patterned relief surface (eitheron the later directly touching the skin or any other layer including theadhesive substrate) to enhance bonding to the subject's skin.

The adhesive holdfast may be made of layers. Thus, the adhesive holdfastmay be referred to as a layered holdfast (or layered adhesive holdfast).For example, the adhesive holdfast may include a substrate (also knownas adhesive substrate) layer to which a biocompatible adhesive isapplied. The substrate is typically a substantially flat (predominantly2-sided) material that is flexible. An adhesive may be present on atleast one surface of the substrate. In some variations, the substratelayer is itself adhesive without needing an additional adhesive. Anadditional protective cover or liner may also be removably attached tothe adhesive of the adhesive layer. The protective cover or liner mayallow the device (and particularly the adhesive holdfast) to bemanipulated without inadvertently sticking the device to the fingers orother parts of the body and it may also prevent contamination of theadhesive. The liner may be a removable paper or other film that can bepeeled off or otherwise removed to expose the adhesive. In somevariations, the adhesive of the adhesive holdfast is activatable. Forexample, the adhesive may become ‘sticky’ only after exposure to anactivator (e.g., water, air, light, etc.) or may increase its“stickiness” after application (for example after exposure to heat fromthe subject's body or skin). In some variations, an adhesive could beapplied to the skin in a liquid form first, than the device is applied.In other variations, the skin of the subject is prepped through normalor vigorous cleaning which may involve the use of solvents or othercleaning substances or fluids. In some variations, a protective cover isnot used. As already mentioned, in some variations, the substrate andadhesive are a single layer, so that the substrate comprises an adhesivematerial, or a material that can be activated to become adhesive.

The adhesive holdfast may comprise any appropriate material. Forexample, the adhesive substrate may be a biocompatible material such assilicone, fabric, cloth, polyethylene, or polyethylene foam. Otherappropriate biocompatible materials (that may be part of the holdfast orany part of the device) may include some of the materials previouslydescribed, such as biocompatible polymers and/or elastomers. Suitablebiocompatible polymers may include materials such as: a homopolymer andcopolymers of vinyl acetate (such as ethylene vinyl acetate copolymerand polyvinylchloride copolymers), a homopolymer and copolymers ofacrylates (such as polypropylene, polymethylmethacrylate,polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate,ethylene dimethacrylate and hydroxymethyl methacrylate, and the like),polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,polyamides, fluoropolymers (such as polytetrafluoroethylene andpolyvinyl fluoride), a homopolymer and copolymers of styreneacrylonitrile, cellulose acetate, a homopolymer and copolymers ofacrylonitrile butadiene styrene, polymethylpentene, polysulfonespolyimides, polyisobutylene, polymethylstyrene and other similarcompounds known to those skilled in the art. Structurally, the substratemay be a film, foil, woven, non-woven, foam, or tissue material (e.g.,poluelofin non-woven materials, polyurethane woven materials,polyethylene foams, polyurethane foams, polyurethane film, etc.). Insome cases, a pad maybe attached to the any portion of the adhesiveholdfast and may be made from woven or non-woven materials, gauze, foam(open or close cell) or other material that may provide hemostasis. Insome cases, the pad also comprises a medicament that can promoteclotting, healing or repair, or provide other medical or non-medicalbenefit.

In variations in which an adhesive is applied to the substrate, theadhesive may comprise a medical grade adhesive such as a hydrocolloid oran acrylic. Medical grade adhesives may include foamed adhesives,acrylic co-polymer adhesives, porous acrylics, synthetic rubber-basedadhesives, silicone adhesive formulations (e.g., silicone gel adhesive),and absorbent hydrocolloids and hydrogels.

In some variations, the adhesive is a structural adhesive. For example,the adhesive may adhere based on van der Walls forces. U.S. Pat. Nos.7,011,723, 6,872,439, 6,737,160, and U.S. Pat. No. 7,175,723 describesetal-like structures whose shape and dimension provide adhesive force.These patents are herein incorporated by reference in their entirety.

The removable liner layer may be made of any appropriate matter that maybe released from the adhesive. For example, the liner material maycomprise craft paper. In some variations, the liner material comprisespolyethylene film, or polyethylene coated paper (e.g. kraft paper) orany plastic or other material described herein. In some cases, differenttypes of liner material may be used in the same device. For example, oneliner material may be used as part of a protective cap and another linermaterial may be used to protect other parts of the adhesive layer (i.e.not in the area of the protective cap. In general, any of the materialscommonly used in the manufacture of bandages (particularly disposablebandages such as Band-Aids™), ostomy kits, and wound care products maybe used in any or all components of devices described herein.

The following materials may be used in any part of the adhesive devices(including the protective and barrier caps or any other 3D formcomponent) described herein: fabric, cloth, latex, polyethylene,polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride,polyvinyl acetate, polyacrylate, styrene-butadiene copolymer,chlorinated polyethylene, polyvinylidene fluoride, ethylene-vinylacetate copolymer, ethylene-vinyl acetate-vinyl chloride-acrylatecopolymer, ethylene-vinyl acetate-acrylate copolymer, ethylene-vinylacetate-vinyl chloride copolymer, nylon, acrylonitrile-butadienecopolymer, polyacrylonitrile, polyvinyl chloride, polychloroprene,polybutadiene, thermoplastic polyimide, polyacetal, polyphenylenesulfide, polycarbonate, thermoplastic polyurethane, thermoplasticresins, thermosetting resins, natural rubbers, synthetic rubbers (suchas a chloroprene rubber, styrene butadiene rubber, nitrile-butadienerubber, and ethylene-propylene-diene terpolymer copolymer, siliconerubbers, fluoride rubbers, and acrylic rubbers), elastomers (such as asoft urethane, water-blown polyurethane), sodium polyacrylate, paperbatteries, and thermosetting resins (such as a hard urethane, phenolicresins, and a melamine resins), and injection moldable materials such aspolyether block amide (e.g., PEBAX®), and the like.

An adhesive layer (or an adhesive holdfast layer) may be formed usingany appropriate method, particularly those described herein. Forexample, an adhesive layer may be formed by cutting (stamping, punching,die cutting, laser cutting, etc.) the adhesive substrate, biocompatibleadhesive, and protective cover into the desired shape. Multiple stepsmay be used to form the adhesive layer. For example, the adhesive layermay be formed by cutting (or otherwise forming) the outer perimeter,then by cutting (or otherwise forming) an inner opening. Any of thesesteps may be combined, as appropriate.

It is not necessary that the entire adhesive holdfast region include anadhesive, although many of the substantially flat holdfast regionsdescribed in the figures may have a biocompatible adhesive over much ofthe skin-contacting surface (although it may be covered by a protectivecover that can be at least partially removed later). In some variationsonly a subset of the holdfast region (including the outer layer)includes an adhesive. For example, the region beneath the tabs or gripsmay not include an adhesive. In some variations, the adhesive medicaldevices described herein are adapted to fit different users having adiversity of sizes and shapes. In other cases, there is an adhesivelayer on both sides of the adhesive substrate. For example, the side ofthe device that is attached to patient's skin may have adhesive on partor all of its skin-contacting surface, and there may be adhesive appliedto part or all of the other side of the holdfast or device to attachvarious 3D plastic pieces (or other components as described herein).

The adhesive devices may be formed by sequentially layering onto abacking layer (or liner) that protects one side of double-sided adhesive(forming the adhesive holdfast), and cutting out (e.g., die-cutting) oneor more openings through this adhesive holdfast substrate.

Medicament

In some versions, the device includes a medicament. As used herein, amedicament includes any substance that may be applied or delivered tothe subject by the device. A medicament may provide a health benefit,including treating a certain health condition. In some versions, themedicament may be an active agent that comprises a drug. In otherversions, the active agent is not a drug and does not serve a medicinalpurpose. For example, the active agent may only provide fragrance. Insome cases, the active agent may be embedded or impregnated in thedevice or components of the device. In some cases the active agent is acoating. A medicament may comprise any compound that is in some wayuseful or desirable for the subject. For example, the active agent maybe any odorant, including: menthol, phenol, eucalyptus, tea tree oil, orany agent that provides a fragrance. Alternatively, a medicament maycomprise a drug with beneficial effects, such as beneficial vasculatureeffects. For example, a medicament may comprise a drug that affects theblood vessels (oxymetazoline or any other vasoactive compound),nasopharynx, airways or lungs (albuterol, steroids, or otherbronchoconstriction or bronchodilation compounds). A medicament maycomprise, for example, an antibiotic or a steroid. Other medicaments maybe topical anesthetics (which may be helpful to numb an area prior to amedical or surgical intervention), and imiquimod and fluorouracil forvarious skin conditions including cancer. The above list of activeagents is not meant to be limiting.

Any medicament, whether therapeutic or non-therapeutic, may be used. Themedicament can take the form of an ointment, balm, cream, salve, liquid,paste, gel, solid, or near solid. Agents that change from solid toliquid (or change from a more viscous liquid to a less viscous liquid)when applied to the subject or when exposed to higher temperatures mayfind use. The medicaments may have medicinal benefit and may beprescription, non-prescription or OTC (over the counter).

A medicament may be placed in or on any portion of the device.Furthermore, the location of the medicament within the device mayspecifically guide the delivery of the active agent. For example, inversions of the device, the holdfast comprises a medicament (e.g.,coated, embedded or otherwise part of the holdfast). In another example,a medicament may be included as a powder or releasable coating. Thus, amedicament may be on an internal or external surface of the device(e.g., pad, holdfast, cap, etc.) or embedded within or on any surface ofthe device. A separate drug-containing region may also be included inthe device. In some cases, a flux enhancer may be used. As an example,for veterinary use, a fragrance such as bitter apple may be applied ordeposited to any portion of the subject devices. Such a fragrance maydeter the animal from removing or chewing on the device.

In some embodiments, one or more components of the device areimpregnated with, contain or are coated with one or more compounds thatmay be inhaled during use. The presence of airflow, heat or otherconditions may facilitate the release of the compound into the air orsurrounding tissues. The compound may be herbal (such as menthol orlavender), chemical or pharmaceutical (such as an antihistamine oranti-asthma drug) in nature. Depending on the compound, the user mightexperience a pleasant aroma (which may soothe or promote sleep oractivity) or medical benefits, such as nasal decongestion or asthmarelief. The compound may be inhaled during all or at least a portion ofthe time the user is wearing the device.

Active ingredients that may find use include: isotretinoin,alclometasone, doxycycline, erythromycin, iodoquinol, hydrocortisone,imiquimod, alefacept, sodium sulfacetamide, sulfur, tretinoin,muprirocin, clindamycin, benzoyl peroxide, fluocinolone, fluorouracil,clocortolone, clobetasol, fluticasone, prednicarbate, adapalene,calcipotriene, minocycline, pimecrolimus, mometasone, sertaconazole,famciclovir, azelaic acid, urea, terbinafine, lidocaine, acetate,ciclopirox, metronidazole, minocycline, naftifine, oxiconazole,finasteride, tacrolimus, tretinoin, itraconazole, diclofenac,tazarotene, desoximetasone, fluocinolone, hydroquinone (including 2 and4%), valacyclovir, doxepin cetirizine, salicylic acid, silversulfadiazine, zinc oxide, silver nitrate, aloe vera, benzalkoniumchloride, dyclonine, LMX or other topical anesthetic, steroids, Aldera,Efudex, phenol, tar (to treat psoriasis), petroleum jelly, VicksVaporRub, moisturizers, oils, extracts, minerals or vitamins andcombinations of more than one of the above compounds. Other medicamentsand inactive ingredients include persea gratissima oil (avocado),ethylhexyl Palmitate, vitis vinifera seed oil, helianthus annuus seedoil (sunflower), isopropyl palmitate, lecithin, sesamum indicum seed oil(sesame), capric/caprylic stearic triglyceride, aleurites moluccana(kukui nut) seed oil, tocotrienol, alcohol, glyceryl stearate, oleicacid, vitamin C, tocopherol, BHT, methylparaben, benzyl alcohol, benzylsalicylate, geraniol, hexylcinnamal, hydroxyisohexyl 3 cyclohexenecarboxaldehyde, butylphenyl methypropional, onion extract, limonene,linalool, terbinafine, butenafine, amorolfine, and tonalftate.

Other compounds that may be used include other antiobiotic andantimicrobials including bacitracin, polymixin B, neomycin and variousdouble or triple combinations of various antimicrobials includingNeosporin. These include but are not limited to: bacitracin ointmentcontaining, in each gram, 500 units of bacitracin, bacitracin zincointment containing, in each gram, 500 units of bacitracin zinc,chlortetracycline hydrochloride ointment containing, in each gram, 30milligrams of chlortetracycline hydrochloride, neomycin sulfate ointmentcontaining, in each gram, 3.5 milligrams of neomycin in a suitable watersoluble or oleaginous ointment base, neomycin sulfate cream containing,in each gram, 3.5 milligrams of neomycin, tetracycline hydrochlorideointment containing, in each gram, 30 milligrams of tetracyclinehydrochloride.

Alternatively, combinations of antibiotic active ingredients mayinclude. (1) bacitracin-neomycin sulfate ointment containing, in eachgram, 500 units of bacitracin and 3.5 milligrams of neomycin in asuitable ointment base. (2) bacitracin-neomycin sulfate-polymyxin Bsulfate ointment containing, in each gram, in a suitable ointment basethe following: (i) 500 units of bacitracin, 3.5 milligrams of neomycin,and 5,000 units of polymyxin B; or (ii) 400 units of bacitracin, 3.5milligrams of neomycin, and 5,000 units of polymyxin B; (3) bacitracinzinc-neomycin sulfate ointment containing, in each gram, 500 units ofbacitracin and 3.5 milligrams of neomycin in a suitable ointment base.(4) bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointmentcontaining, in each gram, in a suitable ointment base the following: (i)400 units of bacitracin, 3 milligrams of neomycin, and 8,000 units ofpolymyxin B; or (ii) 400 units of bacitracin, 3.5 milligrams ofneomycin, and 5,000 units of polymyxin B; or (iii) 500 units ofbacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B;or (iv) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000units of polymyxin B; (5) bacitracin zinc-polymyxin B sulfate ointmentcontaining, in each gram, 500 units of bacitracin and 10,000 units ofpolymyxin B in a suitable ointment base. (6) bacitracin zinc-polymyxin Bsulfate topical powder containing, in each gram, 500 units of bacitracinand 10,000 units of polymyxin B in a suitable (7) neomycinsulfate-polymyxin B sulfate ointment containing, in each gram, 3.5milligrams of neomycin and 5,000 units of polymyxin B in a suitablewater miscible base. (8) neomycin sulfate-polymyxin B sulfate creamcontaining, in each gram, 3.5 milligrams of neomycin and 10,000 units ofpolymyxin B in a suitable vehicle. (9) oxytetracyclinehydrochloride-polymyxin B sulfate ointment containing, in each gram, 30milligrams of oxytetracycline and 10,000 units of polymyxin B in asuitable ointment base.

Additionally, combinations of first aid antibiotic active ingredientsand local anesthetic active ingredients may be used: (1) bacitracinointment containing, in each gram, 500 units of bacitracin and any amineor “caine”-type local anesthetic active ingredient in a suitableointment base. (2) bacitracin-neomycin sulfate-polymyxin B sulfateointment containing, in each gram, in a suitable ointment base thefollowing: (i) 500 units of bacitracin, 3.5 milligrams of neomycin,5,000 units of polymyxin B, and any amine or “caine”-type localanesthetic active ingredient; or (ii) 400 units of bacitracin, 3.5milligrams of neomycin, 5,000 units of polymyxin B, and any singlegenerally recognized as safe and effective amine or “caine”-type localanesthetic active ingredient. (3) bacitracin zinc-neomycinsulfate-polymyxin B sulfate ointment containing, in each gram, in asuitable ointment base the following: (i) 400 units of bacitracin, 3milligrams of neomycin, 8,000 units of polymyxin B, and any amine or“caine”-type local anesthetic active ingredient; or (ii) 400 units ofbacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, andany amine or “caine”-type local anesthetic active ingredient; or (iii)500 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units ofpolymyxin B, and any amine or “caine”-type local anesthetic activeingredient; or (iv) 500 units of bacitracin, 3.5 milligrams of neomycin,10,000 units of polymyxin B, and any single amine or “caine”-type localanesthetic active ingredient; (4) bacitracin zinc-polymyxin B sulfateointment containing, in each gram, 500 units of bacitracin, 10,000 unitsof polymyxin B, and any amine or “caine”-type local anesthetic activeingredient in a suitable ointment base. (6) neomycin sulfate-polymyxin Bsulfate cream containing, in each gram, 3.5 milligrams of neomycin,10,000 units of polymyxin B, and any amine or “caine”-type localanesthetic active ingredient in a suitable vehicle.

Antifungals that may be used include: clioquinol (including 3 percentformulations), haloprogin (including 1 percent formulations), miconazolenitrate (including 2 percent formulations), povidone-iodine (including10 percent formulations), clotrimazole (including 1 percentformulations) and tolnaftate (including 1 percent formulations).Additionally, undecylenic acid, calcium undecylenate, copperundecylenate, and zinc undecylenate may be used individually or in anyratio that provides a total undecylenate concentration of 10 to 25percent.

Acne medications may also be used including: benzoyl peroxide (including2.5 to 10 percent formulations), resorcinol (including 2 percentformulations), resorcinol monoacetate (including 3 percent formulationswhich may be combined with sulfur), salicylic acid (including 0.5 to 2percent formulations-which may also be used for the treatment of warts),sulfur, (including 3 to 10 percent formulations), and sulfur (including3 to 8 percent formulations which may be combined with resorcinol orresorcinol monoacetate.)

The volume of medicament in each device may be approximately 0.1 ml, 0.2ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, 1.0 ml, 1.1ml, 1.2 ml, 1.3 ml, 1.4 ml, 1.5 ml, 1.6 ml, 1.7 ml, 1.8 ml, 1.9 ml, 2.0ml, 2.1 ml, 2.2 ml, 2.3 ml, 2.4 ml, 2.5 ml, 2.6 ml, 2.7 ml, 2.8 ml, 2.9ml, 3.0 ml, 3.1 ml, 3.2 ml, 3.3 ml, 3.4 ml, 3.5 ml, 3.6 ml, 3.7 ml, 3.8ml, 3.9 ml, 4.0 ml, 4.1 ml, 4.2 ml, 4.3 ml, 4.4 ml, 4.5 ml, 4.6 ml, 4.7ml, 4.8 ml, 4.9 ml, or 5.0 ml.

The viscosity of the medicament may vary from 1 cps to 200,000 cps.Generally medium to higher viscosity medicaments may find use includethose with viscosities between 25,000-35,000 cps, between 35,000-45,000cps, between 45,000-55,000 cps, between 55,000-65,000 cps, between65,000-75,000 cps, between 75,000-85,000 cps, between 85,000-95,000 cps,between 95,000-105,000 cps, between 105,000-120,000 cps, between120,000-135,000 cps, between 135,000-150,000 cps and above 150,000 cpsin some cases.

A medicament (such as an ointment or the like) may have the tendency toseep or wick through a gauze, pad, or other substrate that it contacts,especially if the ointment has a relatively low viscosity. This effectmay be worsened if the substrate has holes within it. Ointment that istoo viscous may have a tendency to stick to the protective cap. In somecases, a hydrophobic or hydrophilic pad is used. In some cases, aportion of the device (e.g., a pad) may be treated or covered so as toprevent absorption or wicking of materials. In some cases, paraffin waxor similar materials may be used as a layer under the medicament, underthe pad, under the adhesive, etc.

Materials

Exemplary materials that may be used for use any portion of the adhesivedevices described herein include: metals, plastics, rubbers, ceramics,wood, chrome, or combinations thereof. Other materials may includeacrylics, latex, polyethylene, polypropylene, polystyrene, polyvinylchloride, polyvinylidene chloride, polyvinyl acetate, polyacrylate,styrene-butadiene copolymer, chlorinated polyethylene, polyvinylidenefluoride, ethylene-vinyl acetate copolymer, ethylene-vinyl acetate-vinylchloride-acrylate copolymer, ethylene-vinyl acetate-acrylate copolymer,ethylene-vinyl acetate-vinyl chloride copolymer, nylon,acrylonitrile-butadiene copolymer, polyacrylonitrile, polyvinylchloride, polychloroprene, polybutadiene, thermoplastic polyimide,polyacetal, polyphenylene sulfide, polycarbonate, thermoplasticpolyurethane, thermoplastic resins, thermosetting resins, naturalrubbers, synthetic rubbers (such as a chloroprene rubber, styrenebutadiene rubber, nitrile-butadiene rubber, and ethylene-propylene-dieneterpolymer copolymer, silicone rubbers, fluoride rubbers, and acrylicrubbers), elastomers (such as a soft urethane, water-blownpolyurethane), sodium polyacrylate, thermochromatic plastic, andthermosetting resins (such as a hard urethane, phenolic resins, and amelamine resins).

Biocompatible materials may be used, particularly for those portions ofthe device which may contact a user. In addition to some of thematerials described above, biocompatible materials may also include abiocompatible polymer and/or elastomer. Suitable biocompatible polymersmay include materials such as: a homopolymer and copolymers of vinylacetate (such as ethylene vinyl acetate copolymer and polyvinylchloridecopolymers), a homopolymer and copolymers of acrylates (such aspolypropylene, polymethylmethacrylate, polyethylmethacrylate,polymethacrylate, ethylene glycol dimethacrylate, ethylenedimethacrylate and hydroxymethyl methacrylate, and the like),polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,polyamides, fluoropolymers (such as polytetrafluoroethylene andpolyvinyl fluoride), a homopolymer and copolymers of styreneacrylonitrile, cellulose acetate, a homopolymer and copolymers ofacrylonitrile butadiene styrene, polymethylpentene, polysulfonespolyimides, polyisobutylene, polymethylstyrene and other similarcompounds known to those skilled in the art. Teflon, Mylar, PFA, LDPE,Hytrel, HDPE and polyester may also find use in any components of thedevices. Materials that are biocompatible and/or sterilizable may alsobe preferred, for example, medical grade plastics such as AcrylonitrileButadiene Styrene (ABS), latex, polypropylene, polycarbonate, andpolyetheretherketone. The forgoing materials are intended asillustrations only. In general, the materials used for any of theadhesive devices described herein may be appropriate for in-linefabrication, for example, using a web conversion technique. For example,the materials used to form the various layers (adhesive substrate,adhesive, 3D rigid/semi-rigid structure, etc.) may be an appropriatematerial selected from those described above. Further, the dimensions(e.g., thickness) of such materials may be within an appropriate rangeto accommodate this fabrication technique. Examples of such materialsand fabrication techniques are provided herein. For example, anexemplary class of adhesive devices described herein includes negativepressure wound therapy systems

Traditional negative pressure wound therapy often requires vacuumsources that are bulky, complex, and/or expensive. There is a need fordevices that are more portable, simpler and less expensive. Currentlyavailable devices are generally manufactured with a hybrid method,involving some steps that are performed by machine, and other steps thatare performed by hand. The instant invention may utilize a manufacturingmethod such as web converting that can be fully or partially automated,can be easily scaled and is cost-effective. Web converting can involvedie cutting, island placement, heat seal packaging, printing, conveying,inspecting, and rejecting parts not within set tolerances. With respectto negative pressure wound therapy systems, the instant invention mayuse a web converting method in order to co-manufacture the absorbentpad/dressing and the vacuum interface (e.g., plastic cap hat attaches tothe vacuum tubing) simultaneously. Rather than using slower andrelatively expensive “pick and place” processes, web converting enablesthe invention to be manufactured with less human labor and less cost andincreased speed.

Negative pressure wound therapy devices enable controlled application ofnegative pressure to a wound. A dressing that is sealed against the skinsurrounding the wound is placed on the user and connected to a vacuumpump which pulls negative pressure. The pressure draws out fluid fromthe wound and increases blood flow to the area, facilitating healing andminimizing scar tissue. Large wounds, chronic wounds, pressure sores anddiabetic ulcers may all benefit from negative pressure therapy.

The wound dressing is typically placed directly on the wound. It may bea flexible material to shape to the contours of the wound area, or itmay be a more rigid material in order to better support a seal fornegative pressure. The wound dressing may be impermeable to fluids, ormay be absorbent. It may contain an absorbable matrix. In someembodiments, the wound dressing may contain, or work in communicationwith, another absorbent material, such as open cell or polyurethanefoam, medical gauze or fabric pad. In some embodiments, the wounddressing may contain a layer designed to evenly distribute pressure overthe wound. This layer may contain one or more materials that in some waydeform under negative pressure, such as open cell foam, medical gauze,sponges, other matrix-like materials, etc. In some embodiments, anairlock layer may additionally be added to the wound dressing. In someembodiments, a hydrophilic layer that interacts with any fluid to form agel may be used. In some embodiments, a moisture wicking material may beused. The wound dressing may additionally contain an adhesive for thepurposes of adhering to patient skin around the wound and may be madeout of hydrocolloid. The pad can be cut to size, or can be differentsize and shapes according to the type of wound. Saline or antibiotics orgrowth factors may be dispensed into the wound or dressing. Any of theparts of the device described herein may be impregnated with antibioticsor other medicines.

Turning to the figures, additional exemplary devices, systems andmethods of manufacturing and using them are described. For example, FIG.1 shows a top perspective view of a layered adhesive medical device thatincludes a liner 101 and a medicament 102 that is located on a pad 103.The device is shown in two parts, the liner 101 and cover 107 is shownabove the holdfast with medicament and pad 103; the two parts may becombined so that the liner covers the adhesive surface of the holdfastand the pad. The two parts may be separated to apply to a user. Thelayered adhesive device has an adhesive (also known as adhesive layer)104 that is planar and attached to the adhesive substrate 105 (which maybe referred to as the backing). Together, the adhesive and adhesivesubstrate comprises the holdfast 106 (which may be referred to as aholdfast layer). The device also has a protective cap 107 that serves tophysically protect and prevent the migration of medicament 102 beyondthe area of pad 103 prior to application of the adhesive device to thebody of a user. The protective cap 107 may also serve to seal themedicament so it is not exposed to the outside air, which may harden orotherwise alter the composition or viscosity of the medicament. Theliner 101 (which may also be referred to as a protective cover or cover)can be removed to expose the adhesive before application of the deviceby the subject. Thus, the holdfast layer 106 of the device secures it tothe subject. The adhesive substrate 105 may be made of fabric, foam oranother spongy material, either open or close cell, or may be made ofnon-spongy materials or other materials, such as plastic. This adhesivesubstrate 105 may act as a substrate for the layer of adhesive 104. Insome variations, the adhesive substrate is itself adhesive, such as whenhydrocolloid or hydrogel or the like is used within the adhesive device.The holdfast (and any or all of its components namely the adhesive layerand the adhesive substrate may have holes or perforations along theirentire length, or may have no perforations, or may have perforations insome areas. As an example, in the regions under the pad and/or adjacentto the pad, there may be full or partial thickness perforations in theholdfast. In other cases, there may be no perforations under or near thepad. By having no perforations under the pad, the medicament may becompletely sealed within the chamber defined as the cavity formedbetween the pad and the protective cap. This seal may prevent migrationof the medicament outside the chamber or evaporation of the medicamentthat may harden the medicament. The holdfast layer 106 may havedifferent regions, including regions that house or support rigid ornon-rigid structures that perform some function, and a grip region ortab that may make the device easier to grasp, apply and remove. The gripregion may not have adhesive attached to it, enabling easiermanipulation by the user. Other regions may include regions of moreaggressive and less aggressive adhesive (e.g., more or less adhesivematerial), regions of hydrogel or hydrocolloid material (includingadhesive hydrogels) to help prevent irritation from repeated or extendeduse. Tabs that may be part of (integral with) the holdfast material, ormay also be formed separately, and may be made of different materials.The pad may be made of any biocompatible material. In some cases, it maybe designed to wick fluids or blood. In other cases, it will not wickfluid, blood or medicament. In some cases, it completely blocks fluidsfrom going through the pad, thus maintaining the medicament on the paditself, without saturating the pad. Thus, in some cases, the pad or itstop layer is impervious or relatively impervious to fluids and/or tomedicaments, which may help maintain the medicament on the pad.

FIG. 2 shows a different variation of the adhesive device of FIG. 1. Theprotective cap 107′ has one or more holes 108 that expose the pad andthe medicament to air outside the protective cap. It is possible thatthe adhesive device itself may be sealed within an airtight package orchamber. In other cases, the package in which the adhesive bandage iscontained may not be sealed or airtight. The provision of holes mayallow the medicament to harden or soften as it is exposed to thesurrounding air. In some variations (not shown) a thin layer of film maypartly or completely protect and seal the underside of the protectivecap to maintain the medicament within the protective cap and serve as abarrier between the medicament and the pad or holdfast. The user may berequired to break this layer of film to release the medicament onto thepad for example.

FIG. 2 shows another variation of an adhesive medical apparatus (e.g.,bandage). In FIGS. 1 and 2, the protective cap 107 and 107′ may have arounded, smooth shape. In other embodiments, the protective cap may haveless rounded and more linear features. In still other embodiments, theprotective cap may we wavy, symmetric or asymmetric, or may have unevenfeatures. As shown in these figures, the protective cap is formedcontinuously with the liner 101 (i.e., both the protective cap and linerare integrated), which serves to both protect the adhesive and themedicament until the subject applies the adhesive device. By having asingle integrated piece comprising the protective cap and liner, it iseasier and quicker for the user to apply the device. Further, it will bemore convenient for the user to dispose of a single, larger piece thantwo or three separate smaller pieces (if the liner was separate from theprotective cap). One purpose of the protective cap is to prevent themedicament (which may be viscous, liquid, semi-liquid or semi-viscous)from moving or migrating beyond the pad. Such movement of the medicamentmay otherwise be expected to happen during storage (especially when thedevice is stored on its side or upside down) or during transport of theadhesive device, and which may be worsened by exposure to temperatureextremes, including high temperatures. Additionally, high humidity orrepeated vibration (as might be seen in distribution the product fromthe manufacturer to the store or to the consumer's home) may alsopromote the movement of medicament beyond the pad. Thus, a key role ofthe protective cap may be to ensure non-movement of the medicament priorto the use of the adhesive device. As mentioned previously, there mayalso be a need to seal the medicament on top of the pad and to minimizeexposure to the external environment (e.g., air) so that the optimalproperties of the active and inactive ingredients of the medicament aremaintained as long as possible. Thus, the addition of the protective capmay be important to maximize shelf life of the adhesive device.

In FIG. 3A, the protective cap 109 has a more dimensional, pyramidalshape. Also in this variation, a removable tab 110 is attached to one orboth sides of the holdfast, to enable the user to handle the devicewithout touching the adhesive. An additional adhesive ring 111comprising double sided adhesive is shown circling the pad, providing apotentially more robust and definitive seal for the protective cap, tohelp prevent migration of the medicament from beyond the pad area and topromote an air tight seal. This double-sided adhesive may be stickier orhave greater adhesive properties than surrounding adhesive on otherparts of the adhesive layer.

In FIG. 3B, a top perspective view of an adhesive device is provided(the upper region of the device is again shown above the lower region ina semi-exploded view as in FIGS. 1-3). The device in FIG. 3B is similarto that in FIG. 1, except that that the liners 112 and 112′ are nowseparate from the protective cap 106′. In this case, the user could peeloff both liners and the protective cap independently prior toapplication of the adhesive device.

FIG. 4A provides top perspective views of an adhesive device that is avariant of the embodiment shown in FIG. 1. In this embodiment, the liner101 and protective cap 107 are integrated into single piece. A separateliner 101′ is also shown. On the left, the device is shown prior toremoval of the combined liner and protective cap. On the right, theliners and protective cap have been removed, exposing the medicament 102on the pad 103. Note that the protective cap has served to contain themedicament on the pad 103 and keep it away from the surrounding adhesivelayer.

FIG. 4B is a top perspective view of the device shown in FIG. 4A. FIG.4C is a top perspective view of a BAND-AID brand antibiotic adhesivebandage with a roughly square shaped protective cap affixed to the linerto prevent migration of the antibiotic film beyond the pad. FIG. 4D is atop perspective drawing of the device previously described in FIG. 4C.In some variants (not shown), the adhesive layer near the base of theprotective cap region (where the protective cap attaches to the adhesivelayer) may be more sticky (or in some cases, less adhesive or sticky)than the rest of the adhesive layer present on the device. This variablelevel of stickiness may allow a more definitive seal between theprotective cap and the adhesive layer (compared to the seal between therest of the liner and the adhesive layer), preventing migration of themedicament off the pad. FIG. 4E is a top down perspective view of adevice in which the protective cap is integrated into the packaging orliner.

FIG. 4F is a close-up view of the protective cap 107, which comprises aconvex dome 121 that serves to contain the medicament onto the pad (notshown) of the device. A containment ring 122 is seen at the base of theconvex dome. This containment ring tightly or semi-tightly apposes thepad of the device, serving as a physical barrier preventing the movementor migration of the medicament off the pad. This containment ringgenerally provides a complete barrier around the pad, though in somecases, there may be fenestrations or holes within the containment ringthat allows some movement of medicament outside the ring.

FIG. 4G is a variant of the protective cap seen in prior examples. Inthis case, the convex dome 121 is surrounded by the containment ring122, which in turn is surrounded by an overflow chamber 125, whichserves as a “flash trap” to capture and/or contain any medicament orother material that leaks or otherwise migrates from the convex domeunderneath the containment ring 122.

FIG. 4H is top down view of another embodiment of the protective cap inwhich the convex dome can be “snapped” into a second, deployedconfiguration, in which the dome is now concave and displaced in thedirection of the pad (not shown). This “snapping” action may produce anaudible or softly audible “click” that is meant to engage the user.Further, the displacement of the dome in the direction of the pad servesto spread the medicament previously contained within or on the undersideof the dome onto the pad area.

FIG. 4I shows the protective cap in the pre-deployed (above figure) anddeployed (lower figure) states. Clearly seen is the spreading of themedicament 126 across the pad 127 after the protective cap has beenpressed or displaced by the user.

FIG. 4J is a more-detailed cross sectional view of the device shown inFIG. 4I. The protective cap comprises a top zone 130 which inflectssharply at transition area 133, leading to downward zone 131. Thistransition area is important as it enables a “bi-stable” configurationof the protective cap. That is, the protective cap assumes only one oftwo preferred configurations, pre-deployed and deployed as described inFIG. 4I. Again, the protective cap serves to protect the medicament 126.The cap is tightly apposed again and presses down against the pad 127 atpinch zone 141. Further away from center of the protective cap is anoverflow chamber 138 which circumferentially surrounds the periphery ofthe pad and is intended to capture or contain medicament that gottenthrough or around the pinch zone 141. An extra adhesive zone 135 servesto securely attach and/or seal the edges 139 of the protective cap tothe device. This extra adhesive zone may be more or less sticky thanadhesive elsewhere on the device as it is intended to secure and/sealthe protective cap tightly onto the device and facilitates the pinchzone 141 providing sufficient force to seal the medicament 126 withinthe central portions of the protective cap.

FIG. 4K shows a more detailed view of the protective cap shown in FIG.4J. Several recommended geometric parameters are shown including variousangles defined by the top zone and downward done. These parametersgenerally may be defined by the manufacturing process used. In the caseof in-line forming of plastic sheet in a web converting process forexample, the distance D is greater than two times the height of the capC as shown in FIG. 4. Additionally, the angle Θ is generally greaterthan 10 degrees to help create a “bi-stable cap” that is capable of“snapping” and creating an audible sound and sensation that can be feltor discerned by the user's finger. Further the angle Φ is generallygreater than 5 degrees as smaller angles would be significantly harderto form using available manufacturing processes. Finally, as shown, thethickness of the pad is at least 20% of the total thickness of thedevice (wherein the thickness of the device is defined as the sum ofthicknesses of the adhesive substrate and pad).

FIG. 4L shows an exploded view of an alternate construction of anadhesive device comprising a 3D formed shell which may be heat sealed tothe pad or other portion of the device as well as a gauze portion.

FIG. 4M shows another exploded view of a different embodiment comprisinga protective cap, adhesive substrate and gauze, which is designed toprotect a wound on the user. A medicament may or may not be present inthis device.

FIG. 5 shows a cross sectional view of the device in FIG. 1. Theadhesive substrate 105 is attached to a double sided adhesive 113 whichis itself removably attached to the protective cap 106 which has anintegrated liner. The protective cap 106 serves to protect themedicament 102 that has been dispensed onto the pad 103. The protectivecap 106 has linear elements and corners in this example. The distance Xrepresents the height of the protective cap 106 which is measured fromthe top of the adhesive 113 to the top of the protective cap 106. Thedistance Y represents the length or width of the protective cap 106measured at the base of the protective cap 106. Generally, measurementsof length, width and circumference at the base of the protective cap 106(or base of the barrier cap (which will be defined later) or base of anyother rigid portion of the adhesive devices described herein) begin andend where the protective cap/barrier cap/other rigid portion deflects,bends or is shaped away from the adhesive layer 113 as is shown in FIG.5.

In FIG. 6, a cross sectional view of another embodiment of the adhesivedevice is shown, this time with a protective cap and liner that iscurved, and not linear (straight-angled) as is shown in FIG. 5.

FIG. 7 is a cross sectional view of an adhesive device as shown in FIG.5 or 6 after the protective cap has been removed, exposing themedicament on the pad, prior to application of the device by thesubject.

FIG. 8 is a cross sectional view of the adhesive device shown in FIG. 5or 6 after the protective cap has been removed, exposing the medicament102 on the pad 103, and prior to application of the device by thesubject. In FIG. 8, there is an additional barrier layer 114 and anadditional double-sided adhesive 117 present. The barrier layer 114 mayprevent the medicament from seeping or penetrating or traversing throughthe pad and into the adhesive 113 and adhesive substrate 105. Thus, thebarrier layer 114 may serve as a seal between the medicament and the outportions of the device.

FIG. 9A is a top perspective view of an adhesive medical devicecomprising an adhesive holdfast 150 and a barrier cap 155. This deviceis may be used to treat wounds (especially painful ones), bed sores, andburns. The barrier cap 155 provides a rigid protective barrier thatprotects and prevents harm to the wound as it heals. The barrier cap 155may have one or more small or large holes, which may provide exposure ofthe wound to air. In other cases, no holes or perforations are presentin the barrier cap 155. A gauze, foam or other soft substance which mayhave hemostatic properties, may be held within barrier cap 155, eitheras part of the device or may be inserted by the user or healthcareprovider. A medicament may also be present within the barrier cap 155.

FIG. 9B is a top perspective view of the adhesive medical device of FIG.9A in which the barrier cap 155 has been removed from the rest of thedevice to demonstrate the construction of the adhesive device. Anopening 165 is seen within the adhesive holdfast (through the adhesivelayer and the adhesive substrate layer). A double-sided adhesive 160 isshown attached to the adhesive holdfast and serves to attach and sealthe barrier cap 155. Not shown in FIG. 9B is a liner which is presentalong the entire underside of the adhesive holdfast 150, and covers theopening 165.

FIG. 9C illustrates a cross sectional view of the device shown in FIGS.9A and 9B. The adhesive substrate 150 is shown, comprising the adhesivesubstrate 151 and the adhesive 152. The liner 170 is shown on theunderside of the device. The barrier cap 155 is attached via the doublesided adhesive 160 to the adhesive substrate. A chamber 175 is seenwhich is empty. The angle α (the angle between the outer edge plane ofthe barrier cap and the wall of the barrier cap) is also shown. Thedistance X′ represents the height of the barrier cap 155 which ismeasured from the top of the adhesive 160 to the top of the barrier cap155. The distance Y′ represents the length or width of the barrier cap155 measured at the base of the barrier cap 155. Generally, measurementsof length, width and circumference at the base of the barrier cap 155(or base of the protective cap 106 (defined earlier) or base of anyother rigid portion of the adhesive devices described herein) begin andend where the protective cap/barrier cap/other rigid portion deflects,bends or is shaped away from the adhesive layer 160 as is shown in FIG.9C.

FIG. 9D shows the device of FIG. 9C in which the chamber 175 is filledwith a medicament. In general, chamber 175 can be filled with amedicament 178, or a soft substance like gauze, sodium polyacrylate,foam or other hemostatic compound, or both a medicament and a gauze,etc. In some embodiments, a mesh, filter or other porous or semi-porousmaterial (not seen in FIG. 9D) may be present, attached on top or belowdouble sided adhesive 160 or on top of or below adhesive 152, in bothcases traversing the opening that defines chamber 175. The purpose ofthe mesh or filter is to help partly contain the medicament or gauze,etc. within the barrier cap and/chamber 175 to help modulate or slow itstransit or exposure to the subject's skin.

The angle α seen in FIGS. 5-6 and FIG. 9C will be generally greater than90° and less than 180°, more specifically between 90-95°, between95-100°, between 100-105°, between 105-110°, between 110-115°, between115-120°, between 120-125°, between 125-130°, between 130-135°, between135-140°, between 140-145°, between 145-150°, between 150-155°, between155-160°, between 160-165°, between 165-170°, between 170-175°, orbetween 175-180°. More preferably, the angle α will be between 92-122°which is a convenient range to enable forming of protective cap (orbarrier cap) during web converting while creating a suitable height ofthe protective cap or barrier cap to allow it to contain the pad andmedicament.

In general, in any of the 3D structures (e.g., caps, cover, protectivecap, barrier cap, protective cover, vacuum cap, etc.) described hereinall of the walls may have angle with respect to the perpendiculardirection relative to the base plane of the structure. For example, allof the walls of the 3D structure may be at an angle of between about 58degrees and 88 degrees relative to the plane formed by the outer(peripheral) baser region of the structure. As mentioned above, thisouter base region may have a larger wall thickness compared to all ofthe walls forming the 3D structure (e.g., projecting up from this baseregion).

The height of the protective cap 106 in FIGS. 5 and 6, may refer to thedistance between the top of the adhesive layer 113 and the top of theprotective cap 106 (and the height of the barrier cap in FIG. 9C, whichmay refer to the distance between the top of the adhesive 160 and thetop of the barrier cap 155) may generally be between about 0.1 mm to 3.5cm, in some variations between 0.3 mm and 1.0 cm, in some variationsbetween about 0.5 mm and about 5.0 mm and in some variations betweenabout 1.0 mm and about 3.5 mm.

The ratio of the maximum length of the protective cap/barrier cap(measured on the inside at the base of the protective cap/barrier cap ina direction that is parallel to the adhesive holdfast in the figures) tothe height of the protective cap/barrier cap is generally greater than1:1, more specifically greater than 2:1, or greater than 3:1, though insome cases where the protective/barrier cap is much longer than wide,this ratio my be less than 1:1 or less than 1:2. The maximum length ofthe protective/barrier cap is defined as the maximum distance betweenany two points measured at the base of the inside of theprotective/barrier cap. In other words, this is the maximum internaldistance or dimension measured at the base of the protective/barriercap. This definition applies to any shape of the protective/barrier cap(or any other 3D component in an other device described herein) whetherit is circular, oval, triangular, square, rectangular, or otherpolygonal shape or non-polygonal shape.

The ratio of the minimum length of the protective cap/barrier cap(measured on the inside at the base of the protective cap/barrier cap ina direction that is parallel to the adhesive holdfast in the figures) tothe height of the protective cap/barrier cap is generally greater than1:1, more specifically greater than 2:1, or greater than 3:1. Theminimum length of the protective/barrier cap is defined as the minimumdistance between any two points measured at the base of the inside ofthe protective/barrier cap. In other words, this is the minimum internaldistance or dimension measured at the base of the protective/barriercap. This definition applies to any shape of the protective/barrier capwhether it is circular, oval, triangular, square, rectangular, or otherpolygonal shape or non-polygonal shape. In some variations, because oflimitations of in-line forming during the web converting process, theheight of the protective cap/barrier cap may be limited by the length,width and/or circumference of the base of the protective cap/barriercap. In some variations, the ratio of the height of the protectivecap/barrier cap relative to the area of the opening (surface area) maybe less than about 0.50 (e.g., less than about 0.45, less than about0.4, less than about 0.35, less than about 0.30, less than about 0.25,less than about 0.2). In some variations, e.g., depending on the shapeof the opening, it may be more accurate to describe the height in termsof the total distance of the perimeter (or circumference) of theopening. The terms perimeter or circumference both mean the total lineardistance measured along the inside of a closed curve measured at thebase of the protective cap/barrier cap. As defined herein, the termsperimeter and circumference may apply to any closed curve and need notbe limited to circular shapes. For example, the maximum height of theprotective cap/barrier cap may be a function of the length of theperimeter of the opening formed. Further, the height of the cap/covermay be within about 95%, within about 90%, within about 85%, withinabout 80%, within about 75%, within about 70%, within about 65%, withinabout 60%, within about 55%, within about 50%, within about 45%, withinabout 40%, within about 35%, within about 30%, within about 25%, withinabout 20%, within about 15%, within about 10%, within about 5% etc. ofthe length of the perimeter of the opening.

The thickness of the protective cap or barrier cap in these and otherembodiments may be uniform, mostly uniform, somewhat variable orvariable, which may be defined by the manufacturing methods used andrelative tolerances that are possible. The thickness of this protectivecap/barrier cap and/or liner may be less than about 0.01 mm, betweenabout 0.01 mm and about 0.1 mm, between about 0.1 mm and about 0.2 mm,between about 0.2 mm and about 0.3 mm, between about 0.3 mm and about0.4 mm, between about 0.4 mm and about 0.5 mm, between about 0.5 mm andabout 0.6 mm, between about 0.6 mm and about 0.7 mm, between about 0.7mm and about 0.8 mm, between about 0.8 mm and about 0.9 mm, betweenabout 0.9 mm and about 1.0 mm, between about 1.0 mm and about 1.1 mm,between about 1.1 mm and about 1.2 mm, between about 1.2 mm and about1.3 mm, between about 1.3 mm and about 1.4 mm, between about 1.4 mm andabout 1.5 mm, between about 1.5 mm and about 1.6 mm, between about 1.6mm and about 1.7 mm, between about 1.7 mm and about 1.8 mm, betweenabout 1.8 mm and about 1.9 mm, between about 1.9 mm and about 2.0 mm,between about 2.0 mm and about 2.1 mm, between about 2.1 mm and about2.2 mm, between about 2.2 mm and about 2.3 mm, between about 2.3 mm andabout 2.4 mm, between about 2.4 mm and about 2.5 mm, between about 2.5mm and about 2.6 mm, between about 2.6 mm and about 2.7 mm, betweenabout 2.7 mm and about 2.8 mm, between about 2.8 mm and about 2.9 mm,between about 2.9 mm and about 3.0 mm.

Thickness of plastic sheets to be formed during web converting intoprotective caps, barrier caps, or any other plastic or formed componentin another device described herein may be measured in inches or mm(e.g., 1 inch is approximately 25.4 mm). For example, plastic sheetsmade of any material described herein (including polycarbonate,polyethylene, acrylics or polyethylene terephthalate in many cases) maybe 0.0025″ (0.0635 mm), 0.005″ (0.127 mm) or 0.01″ (0.254 mm) or 0.015″(0.381 mm) or 0.02″ (0.508 mm) or 0.03″ (0.763 mm) or 0.04″ (1.016 mm)or 0.05″ (1.27 mm) or other thicknesses. As further examples, barriercaps may have thicknesses of 0.005″ (0.127 mm) or 0.01″ (0.254 mm),protective caps (including those that “snap” or have bistableconfigurations, may have thicknesses of 0.005″ (0.127 mm) or 0.01″(0.254 mm), negative pressure therapy device plastic caps may havethicknesses of 0.01″ (0.254 mm) or 0.015″ (0.381 mm), ostomy wafers mayhave flared cone thicknesses of 0.02″ (0.508 mm), intraosseous accesssecurement devices may have plastic hub thicknesses of 0.02″ (0.508 mm),and surgical wound protector barrier caps may have thicknesses of 0.01″(0.254 mm). As described previously, the thickness of any or all ofthese plastic components may be variable.

Regions of the protective cap and barrier cap may have thickness that isdifferent from other regions of the protective cap and barrier cap,especially at regions of curvature or where regions have been stretchedduring the forming process. For example, the walls of the protective capor barrier cap (that extend away from the generally planar adhesivesubstrate) may be thinner or thicker than the rest of the protectivecap/barrier cap. As one example, by being thinner than the rest of theprotective cap/barrier cap, this portion of the device may be moretransparent than the rest of the protective cap/barrier cap, enablingthe user to see the pad and/or medicament on the pad. These walls may beprimarily linear as seen in FIG. 5 or may be curved as is seen in FIG.6. Though the terms protective cap and barrier cap are used primarily inthese descriptions of material choice, thickness, and geometries(including lengths, widths, heights, perimeters, angles, rations, etc.),these parameters specified herein also apply to or any other 3Dcomponent in an other device described herein, including by not limitedto wound therapy devices, ostomy wafers, IV stabilization devices,intraosseous access devices.

FIGS. 9E and 9F illustrates different shapes and sizes of the devicespreviously described in FIGS. 9A-D. The adhesive and/or barrier capsshapes can be any polygonal shape including square, rectangle, circle,oval, triangle or variants or modifications thereof. Non-polygonalshapes or irregularly shaped barrier caps and adhesive shapes may alsofind use.

FIG. 9G shows an incision site wound as might be seen after surgery.FIG. 9H shows an adhesive medical device with construction similar tothat of FIGS. 9C and 9D that has been placed on top of the wound toprotect the wound and promote healing. A medicament such as anantibiotic or petroleum jelly may be present in the chamber, providing amoist environment for wound healing. The device shown in FIG. 9G. andother devices with a barrier cap offer several benefits in protecting awound. First, the barrier cap which is semi-rigid or fully rigid helpsstabilize the wound/incision site as the rigid structure that surroundsthe wound helps to keep the wound edges together and generally reducesmovement of the wound's surfaces as it heals. This promotes woundhealing. The barrier cap may have a transparent barrier cap whichenables the user and healthcare provider to monitor the healing progressand confirm that the wound is not infected or inflamed. This wouldminimize the requirement to keep removing and reapply wound dressings tovisualize healing of the wound

FIGS. 9I and 9J show different embodiments of protective adhesivedevices that were described previously. FIG. 9K shows a side view (topdrawing) of the device shown in FIG. 9J and a cross sectional view(bottom drawing) of the same device.

FIG. 9L is a photograph of the device shown in FIG. 9J. The liner isseen through the transparent cap. Transparent, non-transparent, opaque,colored or non-colored caps may find use.

FIG. 9M shows various geometric parameters of devices such as those seenin FIGS. 9A-9L.

FIGS. 9N and 9O are a top view and photograph of similar adhesivedevices. FIG. 9P shows a side view of another adhesive device thatserves to protect a user's wound. Another photograph of a differentembodiment is shown in FIG. 9Q. Any shape or emblem or logo may beimprinted or formed into the plastic cap of this embodiment or any otherdevice described herein. Various geometric parameters are depicted inFIG. 9R. In some embodiments, any of the plastic caps described hereinmay be applied to currently available adhesive bandages which generallycomprise a liner, adhesive layer (onto which a pad is affixed), andadhesive substrate. The cap may be applied to the top side of theadhesive substrate using an round, oval or ring of double-sidedadhesive.

FIG. 9S shows a top view of an adhesive medical device that protectswounds on moveable surfaces such as a finger. An extra adhesive flap isprovided that ensures that the device remains attached to the skin, evenduring movement.

FIG. 9T offers multiple views of an adhesive device that protects aburn. There is a clear cap that allows the user or healthcare providerto monitor the progression of wound healing. An optional vent hole orseries of vent holes may provide exposure to ambient air which may helpwith wound healing.

FIG. 9U shows alternate cap designs. FIG. 9V shows additional capdesigns including those meant to be flexible during a user's movement.

FIGS. 9W and 9X show devices with barrier caps that include openings orwindows. One or more windows may be incorporated into the cap design.These windows allow the healthcare provide or the user to administertopical medications including but not limited to any of the medicamentspreviously listed. In some cases, 2-octyl cyanoacrylate or n-butyl-2cyanoacrylate (such as Dermabond or Indermil or any other medicalcyanoacrylates) may be applied through these windows and onto the skin,to close the wound. By adding a rigid or semi-rigid cap around thewound, it keeps the wound edges together, allowing the cyanoacrylate orskin glue to effectively bond or cure or dry. This may be especiallyhelpful during application of the medical cyanoacrylate as thehealthcare provider's gloves frequently will become stuck to themselvesor to the patient's skin during application of the medicalcyanoacrylate. This also addresses a major issue with applying medicalcyanoacrylates and other similar skin care products, namely that thewound edges separate during application of the product. Thus, thesubject device improves the performance of medical cyanoacrylates.Further, the device prevents the user (especially children) from pickingat the dried medical cyanoacrylate or the wound which may cause theseparation of the edges of the wound and poor wound healing.Furthermore, the device can reduce tension on the skin in otherwise hightension areas, which might otherwise lead to re-opening of the wound. Inother cases, the device may prevent friction or abrasion to the healingwound site. In some cases, a device with no windows (such as those shownin FIGS. 9I and 9J may be applied on top of the wound after the medicalcyanoacrylate has dried, to protect the site during showering andbathing, until the dried adhesive has sloughed naturally.

FIG. 10A shows different shape variations of adhesive devices with pads.Medicament (not shown) may be applied on any of the devices shown. Theholdfast shape may be a circle, square, rectangle, oval, rhomboid,trapezoid, pentagon, hexagon, semi-circle, or any polygonal or shapelisted above. The pad shape (and corresponding shape of the protectivecap) may be circle, square, rectangle, oval, rhomboid, trapezoid,pentagon, hexagon, semi-circle, or any polygonal or shape listed above.Any shape combination of holdfast and pad and/or protective cap may beused. Different, non-standard shapes may also find use, especially whensuch shapes are adapted to be secured on an anatomical body partincluding the finger, hand, arm, leg, trunk, buttocks, back, heal, toeankle, wrist, elbow, shoulder, knee or the like. The adhesive devicesmay have lengths of approximately 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm,18 cm, 19 cm, 20 cm, 21 cm, 22 cm, 23 cm, 24 cm, 25 cm and widths ofapproximately 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, 20cm, 21 cm, 22 cm, 23 cm, 24 cm, 25 cm. Total device circumference or thesummation of edge lengths may be approximately 3 cm, 4 cm, 5 cm, 6 cm, 7cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm,18 cm, 19 cm, 20 cm, 21 cm, 22 cm, 23 cm, 24 cm, 25 cm, 26 cm, 27 cm, 28cm, 29 cm, 30 cm, 31 cm, 32 cm, 33 cm, 34 cm, 35 cm, 36 cm, 37 cm, 38cm, 39 cm, 40 cm, 41 cm, 42 cm, 43 cm, 44 cm, 45 cm, 46 cm, 47 cm, 48cm, 49 cm, 50 cm, 51 cm, 52 cm, 53 cm, 54 cm, 55 cm, 56 cm, 57 cm, 58cm, 59 cm, 60 cm, 61 cm, 62 cm, 63 cm, 64 cm, 65 cm, 66 cm, 67 cm, 68cm, 69 cm, or 70 cm.

FIG. 10B shows several holdfast shapes that are well suited forapplication on face, including on or around the eyes, nose, mouth, ears,brow, chin, etc.

FIG. 11 shows one example of a liner 201 and protective cap 202 of anadhesive device that is designed to administer medicament to a finger ortoe. The protective cap 202 is roughly symmetrically placed in thisfigure, although asymmetric location of the cap (and thus any pad thatit protects) either along the width or length of the device is possible.In this example, the protective cap and liner are integrated into asingle component. The protective cap and liner component may be madeusing in line forming methods or injection molding as described herein.

FIG. 12 illustrates a different embodiment of the protective cap 203 andliner 204 in which multiple holes are located in either or bothstructures. These holes in the protective cap may enable exposure of themedicament to air which may serve to harden or otherwise condition themedicament prior to its use by the subject.

FIG. 13 shows another embodiment of the protective cap 205 and liners206 and 206′ which in this case are symmetrically placed. In thisembodiment, the protective cap and liners are three separate components,as opposed to the unitary construction previously described.

FIG. 14 illustrates the holdfast 212 and pad 210 and medicament 211 foran adhesive device, whose corresponding protective caps and liners wereshown in FIGS. 12 and 13. The pad is roughly symmetrically placed inthis embodiment. In other embodiments, that pad may be off-center ineither of the two axes. This shape of the adhesive device is suited toapplication of medicament to the nails of either the fingers or toes.

Protective and Barrier Caps

The protective caps and barrier caps seen in FIGS. 1-6, FIG. 9, FIGS.11-13 (and the vacuum caps and all other plastic 3D pieces or componentsto be described below) may share similar physical features and may bemanufactured using similar techniques. The protective caps may protect amedicament after the time of manufacturing until the device is appliedby a subject. As such, it may protect the medicament during transportand storage of the adhesive device. The barrier caps may generallyprotect the subject's wound after application, and may also contain amedicament. The protective cap and barrier cap can be made and appliedthrough a variety of manufacturing methods. For example, they may beinjection molded in-line (within the manufacturing line) or off-line andthen fed one at a time or more than one at a time via a bowl feeder tobe applied to the adhesive device. In many cases, the adhesive devicemay be manufactured through a web converting process in which reams ofmaterial (adhesive substrate, adhesive layer, liners, plastic sheet andthe like) are fed and then cut and joined using processes that are wellknown to those skilled in the art. The plastic sheet may be formed(e.g., cold formed, thermoformed, heated then formed) during the webconverting process and then cut in the appropriate shape and accuratelyplaced on the moving or locally stationary web. The width (defined asthe shortest distance across a polygonal shape) of the protectivecap/barrier cap may be the same width as the adhesive substrate. In FIG.1, for example, the width of the protective cap and cover (liner) may beidentical or nearly identical in dimensions as the underlying adhesivesubstrate and adhesive. In other cases, the dimensions of the protectivecap/barrier cap (which may include the liner) may exceed the width orlength dimensions of the adhesive substrate and adhesive byapproximately 0.05 mm, by approximately 0.10 mm, by approximately 0.15mm, by approximately 0.20 mm, by approximately 0.25 mm, by approximately0.30 mm, by approximately 0.35 mm, by approximately 0.40 mm, byapproximately 0.45 mm, or by approximately 0.50 mm. The protectivecap/barrier cap and/or liner shall be placed on the adhesive substrateand adhesive so that any edge of the protective cap/barrier cap and/orliner is approximately 0.05 mm, approximately 0.10 mm, approximately0.15 mm, approximately 0.20 mm, approximately 0.25 mm, approximately0.30 mm, approximately 0.35 mm, approximately 0.40 mm, approximately0.45 mm, or approximately 0.50 mm from the edge of the adhesivesubstrate and adhesive on which it is placed. Accuracy of this placementduring the web converting process or other processes may be accomplishedusing vision systems that may use optics (e.g., optical sensors, lasers,etc.) and devices that are not in registration can be rejected in anautomated or manual process. The protective cap/barrier cap should beplaced symmetrically or substantially symmetrically to the adhesiveand/or adhesive substrate to help ensure that the subject views theproduct as a quality product.

The protective cap/barrier cap may be made from a variety of materialsthat are conducive to injection molding or in-line forming during a webconverting process. These materials include but are not limited topolycarbonate and polyethylene (including high density polyethylene).The protective cap/barrier cap may be any color and may be transparent,opaque or variably opaque. Choice of color and opacity of the protectivecap/barrier cap may be important to protect the medicament from light orother elements which may affect the quality or longevity of themedicament. The choice of color may be cosmetic in nature. For example,the protective or barrier cap can be any color such as blue, red, green,yellow or the like and various shading or gradations in coloring arepossible for cosmetic and non-cosmetic reasons. For example, noveladhesive bandages that have a blue barrier cap may be produced, whichmay appeal to children of fashion-conscious adults. In some cases, thematerial used in the cap (such as some plastics) may partially orcompletely block ultraviolet light, which may help with wound healing,scar prevention or may help prevent discoloration of the wound/skin asit heals. Writing or other marking may be provided on the protectivecap/barrier cap or any other part of the adhesive device including theadhesive substrate or liner. Laser cutting, die cutting or other cuttingmethod may be used to cut the protective cap/barrier cap or any otherpart of the adhesive device, providing novel features or cosmeticbenefits. In some cases, the protective or barrier cap may be shapedinto a functional or whimsical shape, such as child-friendly shapes orthe shapes of various cartoon characters, bugs, sporting goods, or othershapes that may appeal to children or adults. The protective or barriercap may be made from thermochromatic materials that change color withheat. Importantly, the edges of the protective cap/barrier are not sharpand are not likely to cut or otherwise harm a user.

FIG. 15 shows an adhesive device that is shaped to administer medicamentto a toe, including an adhesive holdfast 212 and a pad 210 that iscentrally located. The medicament is not shown in this figure but wouldbe dispensed on the pad 210. The various dimensions of the adhesivedevice are labeled. Length A′ is typically between about 2 cm and about20 cm, for example, between about 3 cm and about 14 cm and morespecifically between about 4 cm and about 10 cm. Length A′ may beapproximately 3.0. cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm, 5.5 cm, 6.0 cm,6.5 cm, 7.0 cm, 7.5 cm, 8.0 cm, 8.5 cm, 9.0 cm, 9.5 cm, 10.0 cm, 10.5cm, 11.0 cm. Length B′ is typically between about 1 cm and about 12 cm,more specifically between about 2 cm and about 10 cm and mostspecifically between about 3 cm and about 6 cm. Length B′ may beapproximately 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm,5.5 cm, 6.0 cm, 6.5 cm, 7.0 cm, 7.5 cm, 8.0 cm, 8.5 cm, 9.0 cm, 9.5 cm,and 10.0 cm. Length C′ is typically between about 1.0 cm and about 9.0cm, more specifically between about 2.0 cm and about 6.0 cm and mostspecifically between about 2.0 cm and about 5.0 cm. Length C′ may beapproximately 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm,5.5 cm, and 6.0 cm. Length D′ is typically between about 0.5 cm andabout 6.0 cm, more specifically between about 0.75 cm and about 5.0 cmand most specifically between about 1.0 cm and about 3.0 cm. Length D′may be approximately 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0cm, 4.5 cm, 5.0 cm, 5.5 cm, and 6.0 cm. Length E′ is typically betweenabout 0.75 cm and about 10 cm, more specifically between about 1.0 cmand about 6.0 cm and most specifically between about 1.5 cm and about5.0 cm. Length E′ may be approximately 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm,3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, and 5.0 cm. The shape shown has beenoptimized to enable delivery of medicament directly to the nail, nailbed, under the nail bed, and surrounding finger or toe tissue to promotea medical benefit. For example, such a device in which the medicament isan anti-fungal ointment may be used to treat nail fungus. The devicewould ideally provide medicament to all parts of the nail and nail bedto maximize therapeutic benefit. Other embodiments of devices may beused to treat heal cracks with various moisturizers and othermedicaments such as urea.

FIG. 16 illustrates the adhesive device 302 of FIGS. 14 and 15 placed onthe subject's toe 300. The nail 301 is shown completely covered by theadhesive device. Not shown is the medicament which is covers the nail301 to provide therapeutic benefit.

FIG. 17 shows an embodiment of an adhesive device designed to adhere tothe subject's skin and to protect various wires 403 (which may be partof other medical devices/sensors as might be seen in the wards or ICU ofa hospital) through the use of a protective cover 402 and an adhesiveholdfast 401. The tunnel created by the protective cover provides aconduit for these wires and protects the wires from damage or lowers thelikelihood the wires will be inadvertently pulled or displaced by thesubject or others. The cross-section shown is triangular; rectangular,hemi-circular/hemi-oval, or any other appropriate shaped cross-section(or combination of shapes) may be used. The protective cover 402 maybebent, curved, or bendable (e.g., having accordion sides) or the like.

FIGS. 18A and 18B show an adhesive medical device that provides negativepressure wound therapy to a subject's wound to promote faster healingand less scarring. FIG. 18A shows the device in an inactivated state.The adhesive holdfast 502 (which may be a hydrocolloid) adheres thedevice to the skin in close apposition to the wound 501. The pad 503 inthis case optionally has holes or fenestrations 504, though in someembodiments fenestrations are not present. A vacuum cap 505 is seen in anon-activated state, in which the wound is exposed to ambientenvironmental pressure (non-negative). Double-sided adhesive 508 isattached to the vacuum cap 505 and to the adhesive holdfast 502.

In FIG. 18B, the vacuum cap 505 has been displaced in a directiontowards the wound and air in the chamber 507 has been displaced outsidethe chamber 507 through the pressure relief element 506. In some cases,the pressure relief element 506 is a valve or serves a similar purposeof a valve, namely allowing air to be evacuated out of the chamber whenthe vacuum cap 505 is pressed down and preventing or minimizing flow ofair back into the chamber. This allows a negative pressure to be createdand maintained (the device is now in an activated state). This negativepressure may be in the 0-200 mm Hg range, more specifically in the10-150 mm Hg range, and in some variations in the 40-150 mm Hg range.The level of negative pressure generated by the device may be variable.When the device returns to an inactivated state (after a period ofseconds, several minutes, 5-10 minutes, 10-15 minutes, 15-30 minutes,30-45 min, 45-60 min, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, 5-6hours, 6-9 hours, 9-12 hours, 12-15 hours, 15-18 hours) then the usercan press the vacuum cap again to again create negative pressure withinthe chamber. Such a device may be worn for hours or days before beingreplaced.

In some embodiments, such as those shown in FIGS. 18C and 18D, a smallexternal suction device (such as pipet bulb or other type of bulbsuction) may be used to provide ongoing negative pressure or to createnegative pressure sporadically. These external suction devices mayinclude bulb suction devices similar to those used to drain chest andabdominal wounds after surgery.

As shown in FIG. 18C, negative pressure wound therapy devices generallycomprise an absorbent pad or other wound dressing 530 (such as ahydrocolloid), a plastic cap 532 and tubing 534 that connects to avacuum source, in this case, a manually-actuated bulb suction device536. A bulb suction device 536 may have capacities between 50 ml and2000 ml and more preferably between (and including 100 ml and 500 ml).Capacities of 100 ml, 150 ml, 200 ml, 300 ml, 400 ml and 500 ml may finduse. Representative negative pressures created by a 100 ml bulb as afunction of bulb volume is shown in FIG. 18E. Generally, it has beenshown in the medical literature that negative pressures between 40-150mm Hg are useful in the treatment of wounds. In use, a bulb suctiondevice may need to be pressed (and negative pressure re-generated)and/or fluid drained on an intermittent basis, for example every fewhours.

As shown in FIG. 18F, the plastic cap 532 may contain one or more portsincluding, for example, a approximately perpendicularly-projectingadapter 544 that connects the plastic cap to medical grade tubing (notshown) which enables fluid (air) communication between the wound and thevacuum source. In many cases, there may be a foam or gauze or otherabsorbent wound interface layer that is placed within the wound of thepatient or on top of the patient's skin or wound, thus serving as apartial or complete barrier between the device and the patient. In somecases, the pad or gauze or other absorbent feature is part of thedevice, for example attached to the underside of the holdfast (such ashydrocolloid or the like). In some cases, the base of the cap can beround, oval, semi-oval, curved, rectangular, square or other geometricalshape. As the plastic cap extends away from the user's skin, the cap mayassume a conical or tapering three-dimensional shape, which has anopening which can be attached to tubing that connects to the vacuumsource. In some cases, a view port may be present on or within the capto enable the patient or healthcare provide to assess the healing of thewound and/or confirm the wound is not infected. In other cases, theentire plastic cap may be transparent or enable view of the healing ofthe wound.

In some embodiments, the negative pressure wound device (including anyand all components such as the tubing or bulb or other fluid collectionmeans) may be held or attached to the patient's body (such as their legor foot) through the use of an attachment means such as tape, gauze,Velcro, strap or the like.

The plastic cap 532 generally has a leak-proof seal to the adhesivesubstrate 530. It also may contain a port or adapter to connect to thevacuum source. This connection to the vacuum source may be through apress fit seal, or other means of connection that is commonly known inthe art. The plastic cap or plastic cover may also contain one or moreother ports—a port to remove waste exudate into a waste receptacle orreservoir, a port to add water, saline, antibiotic or other fluid to thewound area, and/or a viewing area or port that provides a visualindication of the progress of the wound healing.

This cap may be cone shaped and may be manufactured smaller or larger tobe sized for specific wound sizes or common wound locations. Forexample, it may be sized particularly for a common spot for diabeticulcers on the foot or there may be child or adult sizes. The plastic capgenerally is located on top of the hole within the adhesive substrate(or holdfast), allowing the fluid transmission of negative pressure tothe wound.

FIG. 18G shows a slide view of the negative pressure wound therapydressing. The plastic cap 532 is shown, including the adapter 544 whichhas a tapering shape as it projects away from the skin surface. Theadhesive substrate 530 is shown attached to the liner 535.

FIG. 18H shows a cross sectional view of the device shown in FIG. 18G.The liner has been removed and foam 550 is seen between the plastic capand the wound 552. In this case, the foam 550 has been sucked into thechamber within the plastic cap 532 due to the negative pressure createdby the device. In this example, the opening in the adhesive substrate530 is approximately the same size as the base of the plastic cap 532.In other cases, the length of the opening in the adhesive substrate issmaller than the length of the opening at the base of the plastic cap(defined by the internal dimensions of the cap). This ratio between thelength/diameter of the opening in the adhesive substrate 530 to thelength/diameter of the base of the plastic cap 532 (defined by theinternal dimensions of the cap) is generally less than 1:10, less than1:9, less than 1:8, less than 1:7, less than 1:6, less than 1:5, lessthan 1:4, less than 1:3, less than 1:2, less than 1:1.

FIG. 18I shows the tubing 534 attached to the plastic cap via theadapter. FIG. 18J shows a cross sectional view of this attachment, inthis case using a press fit between the tubing 534 and the adapter 544.

The cap may be raised and/or have a hollow space within it. The heightand shape of the plastic cap may be limited by the manufacturing processused (i.e. forming during web converting). The cap may be made out ofany variety of common plastics, such as ABS, PC/ABS, PVC, polypropylene,polyethylene, polycarbonate, or others, or could contain, be impregnatedwith, be adhered to, be coated with, or be manufactured out of anyvariety of biologically compatible materials, such as PEG, PLA, PGA,PLGA, hydrogels, etc. The plastic cap 532 may additionally contain a hubfor the purposes of aspirating wound exudate and other liquids from thewound. An additional tube and suction source may be applied in order toremove this exudate from underneath the occlusive dressing and drain itinto a waste container. Leak prevention mechanisms may be designed intoany of the parts described in this invention. Less than 10 mL of exudateis expected per day for many patients with diabetic ulcers, though insome cases, this may be significantly more, especially for other diseasestates.

As described previously, the device contains tubing between the plasticcap and the vacuum source, which may be made from any medical grade,biocompatible material. The tubing may additionally lock or seal ontothe source of the vacuum via a Luer lock or similar standard sealingsystem, or it may press fit into an inlet sized to make a seal at thatconnection. The tubing material is generally non reactive to and/orcompatible with normal medical device sterilization.

An additional adapter or locking mechanism may be added to the tubing,in order to separate the tubing portion in two parts: a reusable sectionwith in which the tubing connects to the vacuum source, and a disposablesection that attaches to the wound dressing/absorbent pad and isattached to the plastic cap as described previously. This additionaladapter could be any quick release adapter/locking mechanism such thatthe disposable wound dressing section could be taken off, thrown away,and the wound dressing replaced and reconnected to the vacuum source.The adapter material can undergo normal medical device sterilization.

The device shown in FIG. 18F may be used with any source of vacuum,including self-actuating suction bulbs as shown in FIGS. 18C and 18D, ormay be used with any commercially-available vacuum sources, includingthose made by companies such as Kinetic Concepts, Smith and Nephew,Spiracur and the like. Thus, sources of the vacuum may include manualpower, that are self-powered, or that use electrical power, i.e. aportable suction pump, plastic bellows, a manual suction bulb, or wallsuction as is provided by medical providers or hospitals. In someembodiments, a filter may be used in the device assembly in order toprevent or reduce the amount of microbes, exudate, or any contaminationfrom the wound site from reaching the vacuum pump. This filter may be inany position between the vacuum pump and an exudate collectioncontainer, or in the tubing itself.

This therapy can be utilized continuously over a period of a few minutesto a few days, or can be used intermittently throughout therapy forwound healing. The vacuum source may pull a pressure between −40 and−150 mm Hg, but may be optimized to −75 and −125 mm Hg. Consistentpressure may be maintained until the patient interrupts it, it may bevariable, or it may slowly return to zero, thus triggering the patientto reset it. In some embodiments, the device may make use of valves orother viable methods of pressure modulation in order to reduce orincrease the amount of negative pressure delivered to the wound. Thedevice may be configured to provide any suitable or desired level ofnegative pressure at any suitable or desired frequency.

In some embodiments, the device may be configured such that air can onlyflow through the device or parts of the device in one direction, inorder to maximize efficiency of the vacuum applied. This could bedesigned by using one way valves or other methods.

The construction and geometry of the vacuum cap may be similar to thatof the protective cap and barrier cap that were previously described.This includes the angle α and the various dimensional attributes thatwere previously described for protective and barrier caps. In someembodiments, as shown in FIG. 18K, the geometric dimensions of theplastic cap (namely the adapter portion of the plastic cap which isshown with a conical shape) designed to facilitate a press fit interfacewith the tubing. In this example, the diameter of the top of the cone isequal to or smaller than the inner diameter of the tubing to which it isattached. This helps to create a press fit and/or seal between theplastic cap and tubing.

In FIG. 18L, the relative ratio of the length of the adapter portion ofthe plastic cap (“A”) to the internal diameter of the base of theadapter portion of the plastic cap (“B”) is defined. Generally A<3B. Insome cases, A<2B and in still other cases, A may be approximately equalto B. These relative ratios may be defining by the forming process aswell as the materials used and whether heat has been applied. Further,the angle Θ as defined within FIG. 18L is generally greater than 5degrees, as this makes the forming process easier.

FIG. 18M shows another embodiment of the negative pressure wound therapydevice in which the tubing 534 is stabilized onto the adhesive substrate530 by tubing attachment means 555. A cross sectional view of tubingattachment means 555 is seen in FIG. 18N, in which tubing 534 is seensecured within the tubing attachment means 555. Attaching the residualtubing in such a manner makes it less likely for the tubing to beunintentionally pulled off the plastic cap 532, and helps to keep thetubing in a more orderly state.

Alternate embodiments of tubing attachment means is shown in FIGS. 18Oand 18P. The method of securing the tubing within the tubing attachmentmeans is shown in FIG. 18Q. An alternative method of securing the tubingis shown in FIGS. 18R and 18S, prior to insertion of the tubing. Thedevice shown here may have a living (or integral hinge) along its path.FIGS. 18T and 18U show the tubing attachment means after the tubing hasbeen inserted. FIG. 18V shows the insertion of the tubing in the tubingattachment means and FIGS. 18W and 18X show a side and top viewrespectively. FIG. 18Y shows different embodiments of the previouslydescribed plastic cap, including one with ridges to afford improvedrigidity or strength. FIG. 18Z shows a sequential manufacturing methodof forming the plastic cap comprising the first step of forming arelatively smaller (shallower) cap, followed by step of creating a muchlarger cap, followed by a third step of forming a cap that is anintermediate size between the caps formed after the first and secondforming steps.

FIG. 19A shows a standard (prior art) IV catheter that has a insertiontube 600 which extends in the subject's vein, a plastic hub 601, alocator 602 located on the plastic hub, a connection region 603 andtubing 604 which may be connected to an IV bag for example.

FIG. 20 illustrates a subject device that is designed to stabilize an IVcatheter such as the one shown in FIG. 19A. The IV stabilization devicehas adhesive holdfasts 607 and 607′ which are located on either side ofthe plastic hub 601. A fixator 606 releaseably surrounds the locator602, thereby preventing or minimizing the potential for movement of theplastic hub and insertion tube. In some embodiments, the fixator has asecure press fit with the locator 602, leading to a snap fit. In otherembodiments, the fit is less tight, but still secure enough to preventsignificant movement of the plastic hub 601 and insertion tube 600.

FIG. 21A shows a cross-sectional view of the IV catheter stabilizationdevice of FIG. 20. The adhesive holdfast in this case comprises both anadhesive substrate layer 612 and adhesive 611 that is in contact withthe liner 610. The fixator 606 is attached using a double sided adhesive613 which connects the fixator 606 and the adhesive substrate 612. Theangles β and σ are generally >90 degrees. More specifically, a may bebetween about 90-95 degrees, between about 95-100 degrees, between about100-105 degrees, between about 105-110 degrees, between about 110-115degrees, between about 115-120 degrees, between about 120-125 degrees,between about 125-130 degrees, between about 130-135 degrees, or betweenabout 135-140 degrees. More specifically, β may be between about 90-95degrees, between about 95-100 degrees, between about 100-105 degrees,between about 105-110 degrees, between about 110-115 degrees, betweenabout 115-120 degrees, between about 120-125 degrees, between about125-130 degrees, between about 130-135 degrees, or between about 135-140degrees.

FIG. 21B illustrates a variant of the device shown in FIGS. 20 and 21Awherein the double sided adhesive 613 extends into the fixator 606. Thisdouble-sided adhesive is intended to securely fasten the plastic hub ofthe IV catheter (not shown). IV stabilization devices that offer boththe physical securement of the fixator 606 onto the locator 602 (asdescribed in FIG. 20 and FIG. 21A) and the use of double sided adhesiveto secure the plastic hub (as described in FIG. 21B) are also possible.

FIG. 21C illustrates a cross sectional view of another embodiment of anIV catheter securement device, this time intended to secure “butterflytype” IV catheters. As can be seen in FIG. 21C, the wing 655 of the IVcatheter insertion device has been secured within the attachment region650 that is attached via double-sided adhesive layer 651 to the adhesivesubstrate 670 which in turn is attached via adhesive layer 680 to theremoveable liner 690.

FIG. 21D is a top down view of the butterfly type catheter that has beensecured when its wings 655 were slid under tabs 656, 657, 658, 659, 660,and 661 of the attachment region 650 of the IV catheter stabilizationdevice. All of the IV catheter and other catheter securement devices canprevent significant movement of the catheter even when exposed up to 2pounds, up to 4 pounds, up to 6 pounds, up to 8 pounds, up to 10 pounds,up to 12 pounds, up to 14 pounds, up to 16 pounds of force.

FIG. 21E illustrates a subject device that is designed to stabilize anIV catheter. Adhesive substrates 680 and 680′ are attached to wings 682that attach to each adhesive substrate on either side. Hub lock 688 issnapped on top of the IV hub (not shown) and projections 684 abut thebottom of the IV tubing (not shown). Ridges are present on hub lock 688and projections 684 to provide necessary rigidity to the formed plasticparts that may otherwise be too flexible to stabilize the IV hub frommoving. FIG. 21F shows a cross sectional view of the device previouslydescribed in FIG. 21F.

FIG. 21G shows a top view of the IV stabilization device shown in FIG.21E, this time with an IV catheter and IV extension kit in place. Thecatheter hub is clearly seen snugly secured within the hub lock 688.Also seen is the IV catheter indwelling component 691 and the IVextension set tubing 690. Again, projections 684 can be seen. Variouscross sectional views of the device seen in FIG. 21G are seen in FIG.21H. A side profile view is seen of the device in FIG. 21I.

Additionally, another embodiment of an IV stabilization device is seenin FIG. 21J, in which a plastic hub securement means 697 surrounds theIV catheter hub preventing it from movement. The hub securement means isattached on either side to the adhesive substrates 680 and 680′. FIGS.21K and 21L show another embodiment of the IV stabilization device.

FIGS. 21M, 21N, 21O and 21P show another embodiment of an IVstabilization device. In this example, the device includes an IV hubcapture region having a hub lock 688 and a planar base region 682. Thehub lock and base are integral, meaning that they are formed of the samematerial. The hub lock region extends up into a tunnel-like shape havingan elongate length with regions of different heights, including ribbedregions 684. An axially middle region of the lock (‘tunnel’) has agreater height than the narrower end regions on either end of thetunnel, as shown in FIG. 21M. The ribbed regions extend onto the baseregion and may provide structural support (e.g., enhancing rigidity).The entire structure of the base and hub lock may be formed of a singleplanar material that can be pressed or stamped as described above.

In the example shown in FIGS. 21M-21P, a pair of adhesive substrates 680and 680′ are attached to the planar substrates 682 on either side of thehub lock 688. These regions 682 may be referred to as wings. The hublock 688 is shown with ribs or projections 684 providing structuralrigidity. In some variations, rather than outwardly projecting ribs(e.g., having a greater height in the channel/tunnel through the hublock), the ribs may be inwardly projecting, having a lower height in thechannel/tunnel through the hub lock. Distal exit port 687 of the hublock can be positioned over, to surround an extension set tubing thatcould then be connected to an IV bag, for example. In FIGS. 31M-21P, aremovable liner 689 can also be seen over the adhesive. This liner canbe removed to place the device against a patient or structure (e.g.,after placing it over the IV hub). FIG. 21N shows a device having an IVhub capture region including a hub lock 688, planar base regions oneither side (wings) 682, and a proximal port 685. The device may bepositioned on top of an IV catheter 683, as shown, where the catheterincludes a catheter hub 685 and IV extension 686. In some cases, the hublock may be designed to “snap” onto the hub, providing a tactile andauditory confirmation to the user that the securement device has beenapplied appropriately. The geometry of the hub lock 688 may be eithersemi-circular or oval in cross section thorough the tunnel region (e.g.,transverse to the long axis of the channel), with oval or non-circularcross-sections potentially providing more comfort as it may provide lessdownward force on the hub (and therefore less downward force on the skinof the user). Further, proximal port 685 may have a flat orsubstantially flat end (as opposed to having a “tunnel” that may bepresent on the distal end (distal exit port 687). This flat end ofproximal port 685 provides clearance for the wings or other feature ofthe IV catheter 683 that might otherwise be obstructed if the proximalport 685 was not flat or otherwise designed with a means ofaccommodating such wings. For example, in some variations, the openingforming into the hub lock region 685 may have a height that is less thanthe height within the channel/tunnel through the hub lock region, butextends less than a few mm in the longitudinal axis of the channel(e.g., less than 5 mm, less than 4 mm, less than 3 mm, less than 2 mm,less than 1 mm, etc.). In contrast the opposite entrance, distal exitport 687, into the tunnel region may include a ‘roof’ region thatextends in the longitudinal axis of the channel at a lower height thanthe mid-region of the channel for a distance of greater than the extentof the proximal exit port height, e.g., greater than a few mm (e.g.,greater than 3 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm etc.)

FIG. 22 illustrates an adhesive medical device 705 designed to helpstabilize a urinary (Foley) catheter. The catheter 700 is shown. A firstadhesive stabilization device has adhesive holdfasts 701 and 701′ and afixator 702 that is securely connected to the adhesive holdfasts 701 and701′. A catheter 700 is shown being stabilized by the fixator that isgenerally made from a rigid material. This rigid material may be madethrough a web converting process. In this case, upward movement of thecatheter is prevented as the increased width of the catheter at itsbranch 716 will abut the fixator 702. A second adhesive stabilizationdevice 709 is shown attached to the lower portion of the urinarycatheter. Adhesive holdfasts 710 and 710′ are shown securely attached tothe fixator 711. A hub 715 is also shown. The adhesive stabilizationdevice 709 prevents the upward movement of the catheter as the hub abutsthe fixator 711. Downward movement of the catheter will be prevented asthe branching 716 of the catheter abuts the fixator, preventing suchmovement.

FIG. 23 shows a cross section view of both of the adhesive stabilizationdevices shown in FIG. 22. The adhesive holdfast comprises two layers,the adhesive layer 728 and the adhesive substrate layer 726, to which adouble-sided adhesive 724 is attached. Also attached to the double-sidedadhesive 724 is the fixator 722 that releaseably secures the urinarycatheter 720 restricting its movement. A liner 730 can also be seen,which protects the adhesive layer 728 prior to application to thesubject. The liner 730 can have many configurations, including ones inwhich it bends upon itself, to make it easier for the user to remove thebacking or to apply the adhesive stabilization device. The fixatorsdescribed in the prior paragraph are generally rigid or semi-rigid andare formed though a web converting manufacturing process. Many of thethickness, dimensional and material attributes previously described forthe protective caps and barrier caps also apply to the fixators, as theyare all created via similar manufacturing processes. Other embodimentsof related devices may be used to stabilize drains in other bodylocations such as biliary, abscess, feeding tube, naso-gastric ornaso-enteric, or nephrostomy applications.

FIG. 24A illustrates a nasal strip 800 designed to dilate the nasalpassageways to treat allergies, snoring, or the like. FIG. 24B shows aclose of view of the device 800. Multiple ridges 820 are attached viaadhesive 815 to the holdfast 810. The ridges which are generally made ofplastic provide stability to the device. FIG. 24C illustrates a crosssectional view of the nasal strip 800 in which the ridges can be seen.The addition of ridges on top of the nasal strip is to promote increasedforce generation of the nasal strip as it pulls on the outside of thenose, thereby increase nasal patency and improving airflow through thenose. In some cases, the nasal strip may be pre-shaped or pre-formed(for example, the ridges may be pre-formed) to fit on top of the nose(i.e. the device may have a natural curve and not be flat as shown). Byhaving a pre-curved shape, the device may be more comfortable to wearthan a device that is substantially linear prior to application to thesubject. Efficacy may also be improved as a result.

The ridges of this nasal strip may assume any shape including straight,mostly straight, wavy, curvy, or the like. FIG. 24D shows a crosssection of one embodiment of the nasal strip. Additional embodiments areshown in FIGS. 24E-G. FIGS. 24F and 24G show devices that have beenpre-shaped during the manufacturing process.

The subject nasal devices are attached to the exterior of the nasalpassages as shown in FIG. 24H. Compared to other currently availablenasal devices, the subject devices exert less pressure on the bridge ofthe nose (as shown in FIG. 24I) compared to currently available devicesas there is less orthogonal force applied to the nose compared withother devices that do not have a 3D formed plastic component as shown inFIG. 24J.

FIG. 24K shows alternative embodiments of the subject nasal devices.FIG. 24L shows further embodiments of the subject nasal devices in whichthe ridges are not uniformly straight. In some cases, the ridges aregenerally straight near the central portion of the device only to flareor diverge further away from the central portion of the device which mayimprove its ability to dilate or maintain patency of the nasal passages.In some cases, the plastic (or other material that provides structuralsupport or increased rigidity) may be formed in such a way as to createa tab that allows application or removal of the device. Currentlyavailable devices can be difficult to remove from the skin of the user,so the use of such a tab that is raised or otherwise easy for the userto grasp would allow easier removal of the device. This tab could bemade from the same formed material as the ridges as one example. Inother cases, the tab and the ridge may be made from separate materials.FIG. 24M shows an additional nasal strip embodiment.

FIG. 24N shows a nasal strip with a formed 3D component that is curved.Removal tabs 865 are designed to help enable the user to remove thenasal strip after use. Removal tabs 865 may be planar or substantiallyplanar compared with the body of the formed 3D portion of the nasalstrip or may be formed at an angle of between approximately 1-5 degrees,between approximately 5-10 degrees, between approximately 10-15 degrees,between approximately 15-20 degrees, between approximately 20-25degrees, between approximately 25-30 degrees, between approximately30-35 degrees, between approximately 35-40 degrees, betweenapproximately 40-45 degrees, between approximately 45-50 degrees,between approximately 50-55 degrees, between approximately 55-60degrees, and so on (relative to the central body region). The removaltab(s) may be on one side or both sides of the device and may projectoutward from the remainder of the 3D formed piece a distance betweenapproximately 0.5-1.0 mm, between approximately 1.0-1.5 mm, betweenapproximately 1.5-2.0 mm, between approximately 2.0-2.5 mm, betweenapproximately 2.5-3.0 mm, between approximately 3.0-3.5 mm, betweenapproximately 3.5-4.0 mm, between approximately 4.0-4.5 mm, betweenapproximately 4.5-5.0 mm, between approximately 5.0-5.5 mm and so on.The removal tab may be attached to the adhesive holdfast (though in somevariation it is not attached to the adhesive holdfast) and it may havean adhesive layer. In some variations the removal tab(s) do not includean adhesive layer. The device shown in FIG. 24N may optionally have aslight bend across its length which may help enable placement of thecentrally on top of the nose (e.g., over the bridge of the nose).

FIG. 24O shows another embodiment of a curved nasal strip in whichcentral removal tab 866 is located centrally or substantially centrallyon the device. Central removal tab may be located on top of the bridgeof a user's nose (not shown). In use, the user's fingers would hold theremoval tab (or place her finger or finger nail under the removal tab)and pull the tab in a direction substantially orthogonal to the skin, orpull the tab substantially downward (or both) to remove the device. Acentral removal tab 866 may be more comfortable to use than side removaltabs, as the skin below the central removal tab is more closely attachedto the underlying bone of the nose than the skin on the side of the nose(closer to the nares). The central removal tab may be symmetrically (asshown) or asymmetrically (not shown) positioned relative to the midlineof the device. Further, a logo or other embossed feature may be formedinto the central removal tab or any other part of the 3D formedcomponent. The removal tabs described herein are generally attached tothe rest of the 3D formed part or may be integrally formed with the restof the body of the device (e.g., a uni-body construction) although insome cases, the removal tab may be a separate component. In some cases,the removal tab may be an extension of the adhesive holdfast (notlabeled) without an underlying adhesive layer.

FIG. 24P shows another embodiment of a nasal strip with multiple bendsor curves across its length. The central curve 2455 may help withcentral placement on the nose and the lateral bends 2456 may offerincreased mechanical advantage in holding the nares and nasal valveopen. The curves also offer aesthetic benefits. FIGS. 24Q and 24R showadditional views of the device of FIG. 24P.

FIG. 24Q shows a nasal strip with a center section 870 that is curved toform a convex surface (relative to the upper surface of the long body ofthe device) which may be positioned to contact the ridge of the nosefirst during application. To ensure even contact with the nose, thecenter section 870 may have a positive curvature with a radius (denotedR) of between about 10-20 mm and the width of this section (denoted W)that is less than 15-20 mm. The relatively small width may provide aclear registration area for the user to align to the ridge of the nose,especially in poorly lit settings or when the user is drowsy. Morespecifically, radius R should be approximately less than or equal to 5mm, between 5-6 mm, between 6-7 mm, between 7-8 mm, between 8-9 mm,between 9-10 mm, between 10-11 mm, between 11-12 mm, between 12-13 mm,between 13-14 mm, between 14-15 mm, between 15-16 mm, between 16-17 mm,between 17-18 mm, between 18-19 mm, between 19-20 mm, between 20-21 mm,between 21-22 mm, between 22-23 mm, between 23-24 mm, between 24-25 mm,or more than or equal to about 25 mm. Width W should be less than orequal to 10 mm, between approximately 10-11 mm, between 11-12 mm,between 12-13 mm, between 13-14 mm, between 14-15 mm, between 15-16 mm,between 16-17 mm, between 17-18 mm, between 18-19 mm, between 19-20 mm,between 20-21 mm, between 21-22 mm, between 22-23 mm, between 23-24 mm,between 24-25 mm or more than or equal to about 25 mm.

Lateral sections 875 and 875′ in FIG. 24Q are located on either side ofcenter section 870 and may be concave (relative to the upper surface ofthe long axis of the device) in many cases, although in some cases maybe flat or substantially flat. The mechanism for pulling the outersurface of the nose outward (and thereby opening the nasal valve and/ornares) may be exerted by the formed plastic of the body springing backtowards a straight configuration after elastic deformation. In order toapply adequate pulling force to expand the nasal nares and/or nasalpassages, the lateral sections 875 and 875′ may be adapted so that theydon't bow downward excessively (e.g., they are not too concave). By notbeing excessively concave, although as mentioned above, they may beslightly concave, device (and specifically the lateral sections) of thedevice may flex adequately and contact the nose in a tensioned statebefore springing back, thereby opening the nasal passages. FIG. 24Rshows a cross-section of the nasal strip device shown in FIGS. 24Q and24R, with three locations across the length of the nasal strip labeledA, B and C. A is the center ridge, B is the lateral edge and C thelowest point on the concave curve formed at the two side of the device.If a line is drawn connecting A to B, as shown in FIG. 24R, whichdefines a length AB, the normal or orthogonal distance of point C fromthis line is shown as length “d”. The ratio of d:AB should preferablynot exceed 1:6 to maximize opening of the user's nasal passages. In somecases, d:AB is between approximately 1:2 and 1:3, between approximately1:3 and 1:4, between approximately 1:4 and 1:5, between approximately1:5 and 1:6, between approximately 1:6 and 1:7, between approximately1:7 and 1:8, between approximately 1:9 and 1:10, between approximately1:10 and 1:11, between approximately 1:11 and 1:12, betweenapproximately 1:12 and 1:13, between approximately 1:13 and 1:14,between approximately 1:14 and 1:15 between approximately 1:15 and 1:16and so forth.

In general the preformed shapes of the nasal strips described herein areparticularly significant. As discussed above, the elongate body of thenasal device may be relatively rigid. In addition, any of these devicesmay also include additional textures or structural (e.g., stiffening)elements. For example, FIG. 24S illustrates several embodiments of nasalstrips in which a pattern or texture is formed into the 3D formed piece.Further, any of these devices may include colors or surfaceornamentation. For example, a variety or colors are possible. Any of thenasal strips described herein may have a 3D formed component that hasone or more curves of bends to help facilitate placement or improveperformance.

FIG. 25A illustrates a novel finger splint for a finger 860. Such adevice would be helpful for a subject with a broken or sprained fingeror otherwise seeking to prevent of limit movement of a finger or toe.Multiple ridges 875 are seen attached to the holdfast 870. A projectionof holdfast 880 is seen extending proximally onto the hand, providingextra support. FIG. 25B shows a series of plastid ridges 875, 875′, and875″ which when the splint is applied on a subject's finger, providesignificant support, prevent finger flexion and promoting healing. Across sectional image of this novel finger splint would be similar tothe cross sectional image show in FIG. 24C. Other shapes for varioussplints for the body may find use, including splints for any joint inthe human body, especially for “smaller joints” on the limbs, on thehands or feet, fingers or toes, wrists or ankle.

FIG. 26A illustrates the (prior art) placement of an intraosseous needleinto the bone marrow of a subject. FIG. 26B shows a top view of anintraosseous needle securement device. The holdfast 900 can be seen, ascan a lattice 902 (which is generally made of thin plastic). Centrallylocated is the plastic hub 904, in the middle of which is the opening910. On the sides of the plastic hub are ridges 908 which are added toincrease stability of the plastic hub which may otherwise be too flimsyto secure an intraosseous needle. FIG. 26C illustrates a side view ofthe device shown in FIG. 26B. A liner 912 has been added in closeproximity to the holdfast 900, the holdfast comprising both an adhesivelayer and a substrate layer.

FIGS. 27A and 27B are illustrations of various ridges, ribs, and/orstruts that may be added to any plastic cap, hub, barrier cap, or otherplastic or formed component described in this application. These ridgesand ribs may provide increased rigidity to any of the devices show inany of the figures. Without these ridges of ribs, the subject devicesmay not be strong enough to perform their intended function. Further, asmany or all of the plastic three dimensional pieces described herein areintended to be created in-line during the converting process, they arelikely to be stretched and may have areas of weakness that may have atendency to buckle and/or break. The addition of ridges and ribs cansignificantly reduce the likelihood of buckling or breaking.

FIG. 28A is the top view of an ostomy (wafer) device. Holdfast 950 canbe seen, onto which is securely fixed a flared cone 955 that hasinternal ridges 960. Not shown are optional external ridges on the outersurface of the flared cone 955. The ostomy “wafer” illustrated in FIG.28A can be attached removably to an ostomy bag as is seen in FIG. 28C.

FIG. 28B is a cross-sectional view of the device shown in FIG. 28A. Adouble-sided adhesive 970 is shown securely adhering the flared cone 955to the holdfast 950. In this drawing the liner is now shown. An opening965 within the holdfast is shown, allowing the passage of stool. Thediameter of opening 965 is defined as length “A”. This opening 965 cansubsequently be further expanded or shaped by the user to adapt to hisor her ostomy size and shape. The hole 980 within the center of theflared cone 955 has a diameter “B”. In general, B>A in length. In somecases, B>1.5A, B>2A, B>2.5A, B>3A, B>3.5A, or B>4A. Further, the lengthC, which is defined as the length in which base of the flared cone 955is in contact with the holdfast 950, is between approximately 2 and 3mm, between approximately 3 and 4 mm, between approximately 4 and 5 mm,between approximately 5 and 6 mm, between approximately 6 and 7 mm,between approximately 7 and 8 mm, or between approximately 8 and 9 mm.Ample contact between the base of the flared cone 955 is important as itprovides necessary rigidity and securement to the device.

FIG. 28D shows some added dimensions of the flared cone of the ostomydevice and important geometric parameters that both provide amplerigidity and are manufacturable using in line forming during a webconverting process. FIG. 28E, shows an alternative embodiment of theostomy flared cone, as does FIG. 28F. Finally, FIG. 28G illustratesdetails that allow the flared cone to be securely connected with theostomy bag. The ostomy devices (including ostomy wafers) may have flangediameter sizes of 1.5 inch (38.1 mm), 1.25 inch (31.75 mm), 1.75 inch(44.45 mm), 2.25 inch (57.15 mm), 2.5 inch (63.5 mm), and 2.75 inch(69.85 mm) and the like, including intermediate sizes. Also describedherein are adhesive securement devices including a shaped (e.g., formed)layer of material that includes channels/guides and/or capture regionsfor gathering and/or securing a catheter, and particularly aperipherally inserted central catheter (PICC). For example, a PICC maybe a thin, soft, flexible tube used as an intravenous (IV) line;treatments, such as IV medications, can be given though a PICC, andblood for laboratory tests can also be withdrawn from a PICC. A PICC mayhave multiple lumens, e.g., for adding/withdrawing different solutions.The proximal end of a PICC (the non-inserted end) may therefore havemultiple lines feeding into the lumen of the PICC. A PICC may include ananchor which provides structural support for the PICC and may be wherethe single catheter tube may bifurcate into one or more tubes. In somecases this PICC anchor may have a “wing” having holes for sutures to beplaced.

Described herein are adhesive securement devices for use with a PICCthat is formed of a (a “PICC adhesive securement device”) that includeone or more guides for individually holding/securing multiple lines ofthe PICC. These adhesive PICC line guide devices may also include alock, clasp, or holder that may be integrally formed from the body ofthe device and may hold the one or more lines of the PICC in place.

For example, a PICC line guide device with a clamp may include a basethat is formed to include a plurality of projections (e.g., posts,channels, rims, etc.) forming a guide, and also includes an arm (e.g.,clasp arm) configured to bend over and secure one or more lines (or twoor more lines) of the PICC against the base. The base and/or arm mayalso include an adhesive material. For example, adhesive material on thebase may secure the device to the patient, while adhesive material onthe arm (or in some variations on the opposite side of the base) maysecure the one or more lines of the PICC against the base, within theguide formed by the projections. A PICC line guide device may also beadapted so that any anchor (e.g., wings) on the PICC attach to the base.The PICC anchor may engage one or more projections extending from thebase; these anchor-interfacing projections may be separate from, or maybe the same as, the guide projections for separating, securing and/orguiding one or more of the lines of the PICC. An anchor may also besecured by the arm.

FIGS. 29A-29E illustrate one variation of a PICC securement device. InFIGS. 29A and 29B, a PICC securement device (line guide device) is showncomprising a plurality of (e.g., four) rigid or semi-rigid post-likeprojections 2901 formed from a rigid or semi-rigid base that is itselfattached to an adhesive holdfast layer that can attach to the patient.As shown in FIG. 29C, an arm (configured as an adhesive flap) 2903 iswrapped on top of the lines (tubings) 2905 of the catheter and attachedto the adhesive holdfast layer, thereby securing the catheter to thepatient's body. The arm in this example is formed as a hinged orflexible portion of the base 2908 of the device. Any of the devices(including the PICC-securing devices described) may include a liner orrelease liner coving the adhesive material, and configured to bemanually removed.

FIGS. 29D and 29E show an alternative embodiment of a PICC securementdevice in which multiple projections 2911 are formed from a rigid orsemi-rigid base 2915 which is itself attached to an adhesive holdfastlayer. In this example, release liners are used to protect the adhesiveregions (on the base and on the arm) until the device is applied, asillustrated in FIG. 29E. In FIGS. 29A-29E, the devices shown may securein particular the multiple lines of a PICC and may keep them organized,which may advantageously prevent pulling on the PICC and/or tangling,confusion or interference with different PICC lines.

FIG. 29F shows another embodiment of a PICC securement device in whichthe PICC device (not shown) fits securely into the device using one ormore snaps 2934 that are part of the fixation means 2932 which is itselfattached to adhesive holdfast 2930. This structure, including theprojecting snaps, may be formed using any of the techniques describedherein, including in particular the stamping/pressing techniques. Forexample, the projecting snaps 2934 may be initially formed as a regionhaving angled sides, as shown in FIG. 29G. The putative snap may then beformed from this region by cutting (e.g., laser cutting) from above.Each of the sides to be removed (region 2936) is formed at an angle ofgreater than 90° relative to the flat base region 2940, so that a lasermay be positioned above the device and used to cut out the region 2936,leaving behind an opening 2938, forming the snap region.

In some devices described herein, an alignment guide may be present. Forexample, an alignment guide may comprise a visual alignment guide that asubject can look at to align the device (e.g., in a mirror). Forexample, the device may be marked by a shape, a text, or a color, tohelp align the device with a location on the body include the ear canalor ostomy site. In some variations, at least a region of the device maybe transparent or opaque. In some variations, the alignment guide is atactile alignment guide. A tactile alignment guide may be felt by thesubject. For example, the alignment guide may be a ring, ridge, bump,post, or the like. An alignment guide may be a cone or conical region.

In some variations, the device may further include a support frame. Thesupport frame may be removable and/or removably attached to anotherportion of the device including the adhesive substrate, the adhesivelayer or another portion of the device including rigid portions of thedevice that may be made from plastic. For example, the support frame maysupport the device, including the holdfast region of the device, and becompletely or partially removable after the device has been applied tothe subject. In some variations, the support frame remains on the deviceafter application. The support frame may serve to make application ofthe device easier or to prevent the holdfast from unintentionallyattaching to itself, to another portion of the device or to the subject.As mentioned, any of these devices may also include a support frame. Insome variations, the support frame is a support frame layer.

Methods of Making/Manufacturing Adhesive Devices

Different manufacturing methods including web converting may be used tomake the adhesive devices described herein. Multiple layers may belaminated together using heat, pressure or adhesives either alone or incombination. Methods may include cutting, laser cutting, die cutting,jet cutting, or the like. In some variations, thermoforming or coldforming may be used either as part of a continuous process or as part ofa multi-step process. In some variations, casting, molding or injectionmolding may be used. In some variations, silicone or thermoplasticurethane may be used in any or all parts of the subject devices. Meshmay be used in any or all parts of the device, serving as a filter orother role. For example, the mesh may be formed of nylon or otherfibrous materials. In some variations, it may be beneficial to usematerials that are relatively stiff. Exemplary meshes may include:molded polypropylene plastic mesh (e.g., 0.0140″ thickness), precisionwoven nylon mesh (31.2 openings per inch×31.2 openings per inch),precision woven nylon mesh (80×80), precision woven polypropylene mesh(69×69), filter mesh, precision woven nylon mesh (198×198), PTFE diamondmesh, precision woven polyester mesh (109×109), precision wovenpolyester mesh (45.7×45.7).

Portions of the adhesive medical devices may be assembled or joinedtogether using adhesive (e.g., by using the adhesive substrate region ofthe adhesive holdfast), by compression, laminating, by welding, by heatstaking, heat sealing, gluing, or press fitting. Ultrasonic or laserwelding may also be used. The adhesive or layers of adhesive may cutbefore, after or during the process of combining them through theaforementioned processes. In some cases, the unneeded portions ofadhesive or adhesive layers may be cut against (kiss cut) the liner theyare cast on or a process liner. After cutting the liners may be removedcarrying the unneeded portions of adhesive or adhesive layers with them.

The devices described herein may be continuously fabricated, batchfabricated, or fabricated by hand. In particular, the layered devicesdescribed herein may be fabricated by sequentially adding and processingmultiple layers to form the final device and then packaging the finaldevice. A layer may be pre-processed by cutting, trimming, forming,stamping etc., or otherwise modifying it. Processing may be performed bylayering strips or sheets corresponding to the different layers, andcutting or stamping the devices out of the strips or sheets after theyhave been at least partially assembled. The various operations may becombined into single tools or in multiple tools and aligned orregistered to one another using a closed loop system and/or PIDcontroller in and automated, semi-automated or manual system. Theadhesive holdfast layer may be formed by, for example, cutting acontinuous strip of shapes. A three dimensional portion of the device(such as the barrier cap, protective or fixator) may be thermoformed orcold formed and then cut and accurately placed or transferred on themoving web. A three dimensional portion of the device may be formed andconnected to the device in-line as part of a continuous process orformed in a separate process and then attached in a subsequent process.A three dimensional portion of the device may be delivered in acontinuous roll of material or individually (e.g, in a bowl feeder) andpicked and placed onto a moving roll.

Three dimensional forming, and particularly forming in combination withor as part of web processing may be used in fabrication of theapparatuses described herein. For example, a film of polymeric (e.g.,plastic) material may be stamped, pressed, pushed, vacuum formed orotherwise deformed or molded as a step in the web processing of thedevice. In some variations the formed portion may include a metallicmaterial (e.g., aluminum) that can be deformed with the material andalso operate as a barrier for water and oxygen. Forming may be donewithout any heat applied (i.e. cold forming) or with heat applied (i.e.thermoforming). Heat may be applied in various ways including, heatingthe material which is to be formed before it reaches the forming tool,heating the forming tool or both pre-heating the material and theforming tool. Annealing may also be done after forming to give thefinished shape the desired physical properties.

In some variations the formed material may be used to formthree-dimensional shapes, e.g., a cover, protective cap, barrier cap,protective cover, vacuum cap, etc., and may be web processed along withthe other layers, in particular the layer(s) forming the adhesiveholdfast and any backing layer(s). In one example, the apparatus may beformed by a continuous process in which a web (sheet) of plasticmaterial from which the cover or cap (e.g. protective cap) is to beformed is cold-formed by stamping to form a chamber or cavity having adesired dimension. After forming chambers on the sheet, it may becombined (while aligned) with an adhesive layer. In some variations, theadhesive layer may be at least partially cut (e.g. by stamping or thelike) to remove internal regions. The adhesive layer may also bepre-applied to a backing layer on one side. In some variations theadhesive layer forming the holdfast region (including an adhesive andadhesive substrate) may be formed as a preliminary web that is thensequentially or simultaneously combined with other webs, including aformed web forming a cap or cover.

In one variation of a method for forming an adhesive bandage having amedicament may be performed by a combined cold forming or thermoformingand web processing technique. For example, the adhesive substrate may becombined with the adhesive to form a first web. An additional webforming the pad to which a medicament may be applied (including appliedduring the fabrication process), pre-applied, or the like, may be cutand placed onto the adhesive side of the first web. A layer of plasticmaterial that is initially flat may then be cold-formed to form thecover/chambers and placed (e.g. rolled) over the pad and medicament. Insome cases, heated dies are used to form the plastic sheets. In somecases, the medicament may be applied or deposited into the protectivecap or barrier cap or other chamber formed during the manufacturingprocess. This medicament can be deposited on to/into acap/chamber/blister when the web that is receiving the medicament isfacing upward or downward. The combined webs may then be finally cut toform bandages as shown in FIGS. 1 and 5, or other variations. Inparticular, rotary die cutting may be used, and automatic eyeregistration may be used to ensure that cutting, laminating, printing orother processes are aligned appropriately to provide the desiredtolerances.

In some variations, a cold-forming or thermoforming technique may beused in combination with the web processing in which individual layers(webs) are cut before placement and/or after placement against otherwebs. The placement maybe accurate to within a tolerance of less thanabout 1.0 mm, less than about 0.1 mm, less than about 0.05 mm, less thanabout 0.01 mm, less than about 0.005 mm, less than about 0.001 mm.

Another example of a continuous fabrication process including coldforming or thermoforming may be used to form a bandage including aprotective region (cap) such as those shown in FIGS. 9A-9C. In oneexample, the bandage may be formed by placing cut layers of adhesiveand/or adhesive substrate on a liner layer (forming an opening in theadhesive substrate/adhesive) and an additional layer of double-sidedtape or adhesive around the opening, then applying cold or thermo formedcovers/caps that have been cut to size, over the openings and secured bythe double-sided tape or adhesive. As mentioned above, the steps offorming, cutting and placing may be arranged so that the process can becontinuously (and in some cases automatically) performed.

FIG. 30 is a flowchart summarizing how the instant devices may bemanufactured using web converting methods. First, raw materials mayenter the manufacturing process, generally in the form of sheets woundon rolls. The unwinding process unrolls the material, including theadhesive, substrate, liner or combinations thereof. A nip roller may beused during this stage to create and maintain tensioning of the web ofmaterials, and may use independent servo motor control to accuratelymaintain tensioning. Alternatively, a nip roller may be used duringother parts of the process. In fact, a nip roller may be used during anyor all of the parts of the process shown in FIGS. 29A-29E. As oneexample, the nip roller may be used towards the end of the manufacturingprocess (in addition to near the start) to ensure that adequatetensioning has been maintained in the process.

Next, the holdfast (or any or all of its components) may be kiss-cut andany extra waste material may be separated and rewound for subsequentdisposal. The cut pattern is generally optimized to minimize wastage ofmaterials. A punch or other tool may be used to create holes in theholdfast or liner or both. Alternatively, a laser may be used to createa hole or to etch a feature or writing onto the device. Slit cutting(using a rotary cutting tool for example) and spreading of the web(using spreading rollers) may then be completed. Spreading can happen inthe cross-web direction and in machine direction, which may be helpfulin minimizing use or wastage of incoming material. The adhesive devicemay be transferred to new liner if desired. The liner may be folded orslit to ease in the removal of the device.

Precise cutting and island placing of fabric (such as the pad of aBAND-AID) or other material may then be completed, accomplished thoughthe use of a servo-controlled process. A nip roller may be used at thispoint to press the pad onto the adhesive holdfast. Next the plasticsheet may be formed, through the use of cold forming or thermoforming.This may occur using a rotary die tool, with male and female components.In some cases, vacuum and or heat may be utilized to enable the formingprocess. In other cases, vacuum and heat are not required. Astep-and-repeat process (during the forming process) may be utilized. Astep-and-repeat process can permit the utilization of a standard die set(i.e. not rotary) which may allow for tighter tolerances. In othercases, a step-and-repeat process is not used, which may increase thespeed of production and number of units that can be produced in a giventime period. In some cases, sequential molds with identical, similar,different or variable shapes may find use. An annealing step may beadded after forming. A step and repeat process, where a moving web isstopped and then indexed, may also be used in conjunction with acontinuous web converting process. Where the step and repeat portion ofthe web is fed into an accumulator or multiple rollers or pulleys thatindex closer and further from one another as the step and repeat web isfed in. The web may then be fed or pulled from the accumulator at asteady continuous rate.

In general, 0.1-0.3 mm PET and polycarbonate are preferred materials forinline forming operations to make the devices described herein, althoughother materials listed herein may also be used.

The difficulty in forming certain 3D features will vary significantlyfrom device to device. Some important parameters to consider include therelative depth of a given feature compared to its surrounding base ofmaterial (which may include width, length, circumference and perimeterof the base which has already been discussed herein). This may bereferred to as the “depth of draw” and this has been discussedpreviously in depth in the sections related to the protective andbarrier cap. For example, it is preferred that the “aspect ratio” whichis defined as the ratio of width (either short width or long width) toheight (defined as the highest deflection from the base) shall generallynot exceed 1:2. Certain exceptions are possible by increase thecomplexity of the forming operation. Other parameters to considerinclude edge sharpness and material thickness.

Some products may require alignment of multiple cut features in theproduct at different locations (also know as registration). Registrationcapabilities with currently available equipment at high speeds istypically +/−0.030 which means that the position of the formed plasticcomponents may vary in position by that amount during manufacturing.Challenges with registration may be minimized by building all of the cutfeatures into the same tool.

Regarding packaging, packaging may be done inline with cold seal pouchfilm to minimize cost. Tabs or other three dimensional features(including those made from formed plastic) may potentially becomeflattened during packaging as cold sealing is typically done by runningthe product and material between two rollers, one steel and the otherrubber. One solution is to provide relief on of these rollers of othertools to accommodate a 3D part being passed through the line, tominimize the potential for damage to the product.

In some cases, a medicament is dispensed or injected into the cavity ordepression formed during the earlier described forming process. Thedepression may be downward facing so that the liquid/fluid ointment isheld in place by gravity. Next, the formed plastic piece may be cutusing a cutting tool, die or laser. The formed plastic piece can then beaccurately placed on the moving web. A vision system may be used to aidin alignment or to identify processing defects. Adhesives may be used tosecurely fix the plastic formed piece to the holdfast, although in othercases, heat sealing or other bonding methods may find use.

At this point, the individual “final product” may be cut (via diecutting or the like) using controlled cutting techniques under thecontrol of a vision system. Additional inspection/machine vision testingmay be completed to ensure quality of the product, including confirmingthe accurate placement of the pad, pad size, patch (or holdfast) sizeand any other feature such as the location and size/height of the formedplastic piece. Defective pieces may be removed from the lineautomatically or manually. The vision system may also provideregistration feedback to the cut-out die station or other parts of themanufacturing system. A bullnose may also be used to remove any airprior to packaging. Final inspection of the part (visual or otherwise)or testing of an individual part may or may not be required.

The device can then be placed into the packaging and the packing sealedand cut into individual packaging. Various heat settings, pressuresettings or dwell time of sealing may be modified to ensure a good seal.A slit cutting tool may be helpful to create multiple lanes of packagedproduct. A take away conveyor with reject gate or compressed air may beused to remove defective product. Next, cartoning and case packing maybe completed. Any and all parts of this process may be interchanged withany other part. Other parts of the process may be deleted or not used ifnot appropriate. Some parts of the process may be repeated one or moretimes. The process may be broken into multiple steps which may beperformed at different times or on different pieces of equipment.

Regarding packaging, any appropriate packaging technique may be used. Asan example, cold sealing or heat sealing may find use. Foil or filmpackaging or other pouching may be used, which may help preventevaporation of the medicament. Specialized packing such as a flat bedreciprocating packager may find use.

Converter speeds may achieve 30 feet/minute and packaging speeds mayachieve 40 feet/minute. In some cases, the fabricating of the productand the packaging operation may be separate processes. In other cases,they may be connected, part of a seamless single operation ormanufacturing line.

Returning to the figures, FIGS. 31A and 31B illustrate anotherembodiment of an IV securement device. An adhesive holdfast may beattached using adhesive 3108 which is attached to bottom securement door3104 which is connected in turn to top securement door 3102. This deviceincludes a living hinge located between the bottom securement door 3104and top securement door 3102. The Luer lock, also known as the hub, (notshown) can be captured in between the bottom securement door 3104 andtop securement door 3102 when the device is in the closed position (notshown).

In FIG. 31B, the proximal a port 3105 (which faces towards the site ofinsertion into the body) of the bottom securement door 3104 has anopening with a cross sectional area that is larger than the crosssectional area of the opening of the distal port 3106. Further, theproximal port 3105 has a smaller tunnel length (which may be zero) thanthat of the distal port 3106 of bottom securement door 3104. The distalport abuts the hub prevent movement of the IV catheter and hub in thedistal direction. The bottom securement door 3104 and the top securementdoor 3102 may be held together by a snap feature on one side. On theother side is a living hinge 3114. The device is designed to fitsecurely on the Luer lock (or hub) slightly the device is in the closed,deployed position (ie when the top and bottom securement door componentsare together). This provides both a snug fit on the Luer lock andprovides a preload that takes up any slack on the snap.

Multiple ribs may be included to reinforce the cap's thin cross-sectionand provide stiffness and maintain the shape while forming. Additionalribs may be located adjacent to large features, terminating at theliving hinge to ensure only the desired bending area is bent duringfolding. The top and bottom features are stamped or formed from a singlesheet in one more forming steps (in the same station or across multiplestations). The snap features can be pre-cut or laser-cut post-forming.

FIGS. 31C-F show additional images of the device of FIGS. 31A and 31B.

FIGS. 32A, B, D and E illustrate a PICC/CVC (peripherally insertedcentral catheter)/central venous catheter) securement device. In FIG.32A, the adhesive holdfast 3200 and liner 3202 can be seen on both sidesof the PICC anchor cap 3208. The PICC anchor cap 3208 is a rigid orsemi-rigid, formed component that is placed on top of the rigid orsemi-rigid PICC anchor (labeled as 3213 in FIG. 32C) which waspreviously described. The PICC anchor, which may or may not have wingsfits at least partially firmly or firmly or in some cases snaps infirmly into the PICC anchor cap 3208. In this “top-down” type device,the PICC anchor cap 3208 is used to hold the PICC catheter securely andmay or may not apply downward pressure on the PICC anchor against thepatient's skin. The bifurcation area of the PICC anchor (where two ormore tubes of the PICC emanate from the anchor—labeled as 3216 in FIG.32C) is a relatively rigid and secure location to anchor the catheter.The PICC anchor cap has a bifurcation area 3206 (in this case for a PICCwhich bifurcates into two tubes—ie a “dual lumen PICC”) which isdesigned to receive the bifurcation area of the PICC catheter. In somecases, the PICC anchor cap will have a silhouette or outline whichsubstantially matches the outline of the PICC bifurcation area or theentirety of the PICC anchor including wings in some cases. A shallowanchor cap may apply relatively more pressure onto the PICC anchor andthis pressure may be transferred to the user. A taller anchor cap mayminimize downward pressure applied to the PICC anchor and thus thepatient. Further, a taller anchor cap may secure the PICC cathether moresecurely as the PICC catheter is less likely to be able to slide underthe PICC anchor cap. PICC anchor abutment 3207 can also be seen andhelps to prevent the PICC catheter from moving in the distal direction(away from the insertion site).

FIG. 32B shows an exploded view of the device shown in FIG. 32A. In thiscase, the liner 3202 folds onto itself although in other embodiments,the liner may be a single layer. A double-sided adhesive 3218 is shownwhich attaches the adhesive holdfast 3200 to the PICC anchor cap 3208.Also seen is small cutout 3220 which enables the wings of the PICCcatheter (not shown) to be placed within the PICC anchor cap 3208without being obstructed by the double-adhesive during placement. FIGS.32D and 32E show finished prototypes of the devices shown in FIGS. 32Aand 32B.

In FIGS. 32F-H, another embodiment of a PICC securement device isillustrated, this time featuring a living hinge. In this embodiment, thePICC anchor 3246 is captured or secured from both the top securementdoor 3238 and bottom securement door 3254 of the securement device. Aliving hinge 3250 is seen connecting the top securement door 3238 andbottom securement door 3254, allowing the device to open and closearound the PICC anchor. There may be high friction between the PICCanchor and the glossy formed plastic material (such as polycarbonate)used for the securement device which helps secure the PICC anchor intothe PICC securement device. The securement device (including the top andbottom securement doors) may be slightly undersized relative to the PICCanchor so the PICC anchor is very secure upon closing/locking of thedevice.

On the bottom securement door 3254, several formed features capture thebase of the PICC anchor preventing it from moving up/down or side toside. The PICC bifurcation area (defined above) where two or more tubesemanate from the PICC anchor is held in place by one or more projections3252 and 3240 that are formed from either the top securement door 3238,the bottom securement door 3254 or both. These projections help preventmovement of the PICC anchor, especially in the distal direction (awayfrom the insertion site). Further, abutment 3239 also prevents thisdistal movement of the PICC anchor. The wing of the PICC anchor may alsofit into a recess that is preferably formed into the bottom securementdoor, again to help prevent the PICC from bring pulled out distally.

The top securement door 3238 exerts continuous downward pressure andkeeps the PICC anchor from being displaced out of the device. Theproximal end of the cap 3230 also constrains the wing from being pulledin the direction of the insertion site. Ribs or ridges can be placed inone or several locations on the top securement door 3238 and bottomsecurement door 3254 including next to large formed features such as3242 or on or near large flat surfaces to maintain flatness (and reducewarping of formed parts).

Snap 3256 and cutout 3234 are present in the securement device and holdthe top and bottom halves together in the closed position. One or moresnaps or cutouts may be on the top anchor or the bottom anchor door orboth. Closure of the device is facilitated by formed corrugations 3232which the user's fingers press down on to engage the snap. Thesecorrugations may also increase the rigidity of the snap area, providingstructural support for the entire device.

FIGS. 32I-K are images of prototypes of the devices described in FIGS.32F-H.

Preventing Warping of Formed 3D Parts

Any of the device described herein may include one or more features,including structural features (e.g., creases, patterned wrinkles and/orraised patterns) to help prevent warping and allow the surface to layflat. In general, particularly when forming flat sheets of material intothe 3D structures described herein by pressing or stamping, flat sheetshave a tendency to warp during the pressing/forming process, dependingon material properties, material thickness, mold configuration,temperature of dies, number of dies and their sequence, depth of draw,etc. During die pressing, the die may not be able to maintain a flatshape because the die may only deform the plastic within an elasticrange. The material may spring back or return to a warped shape afterthe die is released as the residual stresses in the adjacent formedfeatures start “pulling on” the flat area. This warping phenomena isillustrated in FIG. 33A. In this case, a 3D structure 3305 was formed bythe pressing/stamping technique described herein, however warping ofpreviously flat sections 3307 of the plastic sheet occurred.

In some variations, otherwise flat surfaces (e.g., horizontal surfaces)may therefore be patterned to prevent or limit the warping. In general,a raised pattern may be formed in the horizontal regions (e.g., baseregions), as illustrated in FIGS. 33B and 33C. In FIGS. 33B and 33C, theotherwise flat, horizontal surfaces of the device have been press formed(e.g. at the same time, before or after forming the rest of the 3Dstructure(s) of the device) to create shallow ribs running along flatareas that give it a frame of rigidity. In FIG. 33B, the latticestructure is generally square and in 33C, the lattice structure isgenerally triangular. Ribs such as 3302 can be seen in both figures andtheir addition may help maintain flatness of material that may otherwisewarp. Further, ribs or ridges may be applied wherever extra strength isrequired or when large flat areas are present. In general, the raisedpattern (including intersecting ribs as shown in FIGS. 33B and 33C) mayproject above or below the ‘neutral’ height of the sheet being formed byno more than about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 m, 1.3 mm, 1.4 mm, 1.5 mm, 1.6mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5mm, etch. In particular, the height of the raised regions may be lessthan 2 mm. The actual height may depend on the location of other formedfeatures and the extent of flat features. Elongate, and in somevariations interconnecting and/or intersecting projections (ribs) mayproject enough to provide some stiffness or rigidity to the flat surface(e.g., a rim region, or wing region around a device) but may be short orshallow enough not to interfere with the operation of the projectingregion. In addition, the spacing between projections (ribs) may belarger or smaller, depending on the desired stiffness. For example, apreferred rib height to distance between ribs may be larger than 1:8,larger than 1:7, larger than 1:6, larger than 1:5, larger than 1:4,larger than 1:3 or larger than 1:2 depending on application. Generally,the closer the space, the stiffer the overall (‘flat’) region may be,depending also on the shape of the projections. For example, theprojections may have a curved cross-section (e.g., semi-circular orsemi-ovoid) or polygaonal cross-section (e.g., triangular, rectangular,etc.), etc.

In addition to the cross-sectional shape of the raised projections, theoverall pattern of raised projections (e.g., ribs), may be configured toincrease or decrease the stiffness. For example, a square latticepattern as shown in 33B may provide stiffness in two general directions,but may allow warping in the diagonal directions (relative to thesquares in the pattern) whereas triangular patterns (such as seen inFIG. 33C) do not. The choice of lattice geometry may also depend on thethickness of material, the depth of draw of nearby 3D shapes, the areaof desired flat geometry and cosmetic concerns. Exemplary latticegeometries may include circular, triangular, rectangular, square,trapezoidal, pentagonal, hexagonal, heptagonal, octagonal, or any otherpolygonal geometry with equal or variable line segments. Asymetricgeometries may also be used. In general a shallow raised pattern ofinterconnected raised projections as described herein may extend overthe majority of a surface (e.g., horizontal surface). Also, acombination of the above structures is also possible, includingcombinations of patterns and/or combinations of cross-sectional shapes.Further, variable raised projection heights (e.g., rib heights) may beused.

In some variations, these raised projections may be compressed orflattened during the fabrication technique to reduce the profile and/ormodify the physical properties such as stiffness, of these otherwiseflat regions. For example, after forming the projecting regions, theymay be stamped flat or pressed (at an angle). This is illustrated inFIG. 33D. FIG. 33D shows a sequence of forming steps that may be used toproduce a planar or substantially planar structure that neverless doesnot include warping that may otherwise occur when forming devices asdescribed herein. In this example, the flat sheet is initially stampedto form the pattern, which may include a raised projection pattern onthe horizontal regions. In the middle step shown in FIG. 33D, only theraised pattern is shown (additional 3D structures, such as projections3305 shown in FIG. 33A, may also be included. These horizontal regionsmay then be mechanically flattened (or crushed) to form a flat (e.g.,horizontal) surface that neverless includes a crushed pattern of theraised surface, as shown in FIG. 33D (bottom). In some cases, the sameprinciple of sequential forming shown in 33D can be used to producenon-planar, substantially non-planar or other 3D formed structures withminimal warping. During the forming process, such as the processillustrated in 33D, it is possible to form ribs, and then crush themwith a second pass to force plastic deformation into the final shape,which may be planar, substantially planar, non-planar, substantiallynon-planar or a combination thereof. The process of forming this crushpattern may result in a pattern in which flattened raised structures areapparent on these horizontal surfaces; the flattened raised structuresmay overlap against each other in and/or adjacent to the formerly raisedregions.

Draft and Radius Control:

FIG. 34 shows a 3D formed part, with two different radii of curvaturemarked, “r” and “R”. When forming less complex or less deep features, adraft of approximately 3 degrees, approximately 4 degrees, approximately5 degrees, approximately 6 degrees, or approximately 7 degrees may beused. For deeper and/or more complex features, a draft of approximately8 degrees, approximately 9 degrees, approximately 10 degrees,approximately 11 degrees, approximately 12 degrees, or approximately 13degrees may be used. Compound curves may increase the chances of plasticwarping during forming and may create fold marks on the plastic. Sharpangles on vertically-oriented edges should ideally be avoided as a sharptool may slice through the plastic being formed. Adding a fillet (e.g.,a band or ribbon region around the structure) that is about 0.5 mm orgreater to these edges may be beneficial.

In some variations, ribs or ridges may be positioned around the sides ofsome or all of the large features being formed. For example, ribs orridges may be approximately 1 mm wide, approximately 2 mm wide,approximately 3 mm wide, or approximately 4 mm wide to support the sidesof large features. As mentioned above, shallow projections on the flatsurfaces (e.g., interconnecting patterns) may be used (e.g.,approximately 2 mm wide/1.5 mm tall ribs) to add rigidity. At the baseof isolated tall and thin features a fillet radius of between about 0.2mm to 0.8 mm may be used, more ideally between 0.3 mm and 0.6 mm andmost ideally between 0.4 mm and 0.5 mm should be added to the base tohelp material flow.

To facilitate forming, a radius of 0.25-0.75 mm, more ideally from0.35-0.65 mm and most ideally between 0.45 and 0.5 mm on horizontaledges is adequate for features 3 to 6 mm thick. For shallower featuresit may be beneficial to reduce the gap locally between the dies, reducethe fillet radius to 0.15-0.35 mm, more ideally from 0.2 mm-0.3 mm andmost ideally to approximately 0.25 mm and possibly design bend angles tobe 5 to 10 degrees sharper than seen on the features to compensate forthe material springing back. Shallow features generally require sharperbends to form.

Forming with Progressive Dies:

Any of the structures described herein may be formed by the stampingtechniques described herein. In particular, any of these devices may beformed by a plurality of repeated stamping steps (e.g. progressive,overlapping stamping) which may help shape and form the devices. Forexample, a relative taller feature may be formed using a series offorming steps with different dies or the same die that progressivelyforms the feature into its final shape. This may include one step, twosteps, three steps or four steps or more all of which may happen onsingle tool or single station of the press or across two or more toolsor stations. This is illustrated in FIGS. 35A and 35B. In general, thepress-forming (e.g., stamping) techniques described herein may alter notonly the height (z) of regions of a sheet of material to form a 3Dstructure, but iterative stamping (press forming) may also be used tomodify the base size (x,y) of the sheet.

In practice, the multiple stamping steps may be built into a singledie/tool with several spring loaded and/or static forming features thatengage the material at the same time with various spring coefficients orat different times during the forming process. This may be done withforming features in one or both sides of the tool that form material andthen are removed as following forming features are engaged.

In some variations, the forming techniques described herein may extendthe structures being formed out of the plane of the material (e.g., inthe z direction) without substantially changing the size of the plane.Alternatively, the size of the plane (in x,y) may be changed as theheight of the projecting structures(s) is changed.

For example, in FIG. 35A, the first forming step (first image on left)leads to an intermediate piece that has a certain depth and width. Inthe second forming step, the piece becomes deeper (taller) but retainsapproximately the same width at the base. A third forming step producesa taller final piece that is deeper and maintains roughly a similarwidth of the bases as after the first and second forming steps. Thus,this process shows the progressive increase in one dimension duringsequential forming steps.

Alternatively, FIG. 35B demonstrates a sequence of forming processes inwhich the width of the structure (and the width of the base region) ischanged with sequential presses, forming the projection region. Thefirst forming step leads to an intermediate piece that has a first depthand width. The second forming step (in the middle of FIG. 35B) thenleads to the forming of a deeper (taller) intermediate piece, but inthis case, the width 3509 at the bases has decreased. In the finalforming step of the example of FIG. 35B, the piece is formed to becomemaintain the same depth (although in come cases, it may be formed tobecome deeper) and again, the width at the base has again decreasedcompared to the previous forming step. Thus, FIG. 35B shows how asequence of forming steps may lead to intermediate or final formedpieces that can have either increasing lengths in some dimensions anddecreasing lengths in other dimensions. The benefit of progressive (overthe same region of material) forming operations is to enable a deeperdraw or more delicate or complex 3D structures, while minimized crackingof the plastic being formed and/or warping. Additionally, sequentialforming operations also provides the additional benefit of more uniformthickness of the formed material, ensuring more uniform strengththroughout all portions of the 3D formed part.

FIG. 35C shows difference sizes and shapes of formed 3D structures. Inthis case, the depth of feature “A” is less than feature “C” which isless than feature “B”. In general, features with depth of “A” are fairlysimple to form, as the depth of draw is relatively small and the base isnot too small. Feature “C” is considerably more difficult to form thanfeature “A” as its depth is significantly larger with less of a relativeincrease in the width of the base. Forming feature “C” is thus moredifficult and the piece is more likely to break during forming and/orthere may be variable thickness of material (and therefore strength) atdifferent locations of the feature. Feature “B” is in fact easier toform than feature “C” as the opening (or lack or material) under thecurve enable easier forming. In a similar manner, creating one or more“steps” within the formed material can allow the forming of relativelydeep 3D formed structures. The iterative forming (stamping/pressing)steps described above may be used to form any of these types ofstructures, but may be particularly useful in forming structures such as“C” in which the structure extends from the base to a relatively tallheight around the entire circumference of the structure.

In operation, any of these structures may be formed in rapid succession(e.g., stamp or pressing steps) or they may be formed with a delaybetween steps. The stamps may include an alignment guide to help alignthem between stamps/pressing steps; in some variations the previouslystamped shape may be used as an alignment guide. In some variations apressed alignment guide shape may be formed during an earlier step to beused for alignment during a later step.

Any of the variations described herein may include a living hinge. Forexample, FIGS. 36A-F illustrate various embodiments of living hingemechanisms that find use in the subject devices. FIGS. 36 A and B show aplanar sheet that has a series of grooves or lines with decreasedthickness that are arranged in a parallel manner. As shown in 36B, theplastic sheet now has the ability to bend along this joint, thus servingas a living hinge. These grooves of indentations can be formed into theplastic during manufacturing.

FIG. 36C uses many small perforations to weaken the plastic, allowingthe plastic bend on itself, again serving as a living hinge. Theseperforations may be created during web converting through the use of alaser cutter or cutting tool or other die. FIG. 36D uses multiple bendsor small cutouts (which can be removed using a die or using a lasercutter) to enable bending. FIGS. 36 E and F show alternative embodimentsof living hinges. In some cases, it may be necessary to reinforce areaswith ribs where bending is undesirable.

Other alternative means of creating a living hinge mechanism includecreating numerous parallel cuts that soften the material, therebyenabling bending or using multiple parallel half depth cuts, again withthe goal of enabling bending of the plastic. In addition, the top andbottom piece can be formed in two sheets then stacked on top of eachother then glued together at the hinge location. This provides a hingethat has the tendency to close instead of staying open.

As shown in FIG. 36F, to achieve a 180 degree bend, a combination ofmore gentle bends 3610 and a step down 3620 may help achieve thebenefits of a living hinge.

Snap/Locking Mechanisms

FIGS. 37A-O illustrate various snap/locking mechanism, for example thosethat could be incorporated in a living hinge securement devices, or tootherwise connect two structures together (even if not formed of thesame piece and connected by a hinge). The first type, seen in FIG. 37Ashows an independent boss 3700 which is formed and then cut (with alaser cutter, e.g., from a vertical or non-vertical direction) to yielda smaller boss 3710 with an undercut created post-forming. As mentionedabove, the outwardly sloping face 3705 enables such laser cutting of theundercut. A completely vertical face would be more difficult to cutusing a laser cutter mounted above the converting line. In other cases,the undercut is formed by pre-cutting the material or cuttingpost-forming. Thus, in general, any of the walls of the structuresformed, and particularly those having cut-out regions, may be configuredto allow cutting from above, and particularly laser cutting, but havingan angle that is greater than 90° relative to the horizontal (flat) baseor plane of the device. For example in FIG. 37A, the wall to be cut 3705is at an angle of between about 91° and 97° with the base region. Ingeneral, the walls to be cut or trimmed may be formed at an angle ofgreater than 91°, such as greater than 92°, 93°, 94°, 95°, 96°, 97°,98°, 99°, 100°, 101°, 102°, 103°, 104°, 105°, 110°, etc., when measuredup from the horizontal plane of the base. Thus, looking down on the wallfrom above or below the base, the wall includes a portion of the surfaceagainst which the laser cutter may engage to cut the edge.

In a separate embodiment, shown in FIG. 37B, there is a straight boss3720 with a separate part that overlaps the boss which has short flaps3730. The flaps self-lock onto the boss when pulled the other way due tofriction and its steep angle relative to the surface. In come cases, thestraight boss may have grooves (not shown) into which the flaps may fit.The boss may be approximately 4-7 mm tall and 3 mm wide at the top,drafted at 3 degrees or less from vertical. The flaps may beapproximately be 2.5 mm long and interfere with the boss by 0.5-0.7 mmwith a sharp cut edge. To release the latch the flaps are forced to flipdownwards. Thus the length of the flap and interference controls howmuch force is needed.

In FIG. 37C, a separate embodiment involving a simple tab 3740 and hole3750 is shown. In FIG. 37D, another embodiment for the locking mechanismis shown.

FIG. 37E shows some images of the necessary geometries needed tooptimize such locking mechanisms. The length of the underside of thehook 3780 should have ample clearance that is roughly 3-5 times thethickness of the material being formed to account for warping of thefemale part and cut tolerances. In FIG. 37F, the snap should have aslanted undercut 3777 of between 10-35 degrees relative to thehorizontal plane. The slack should be taken up by applying a preloadingforce either by the material's natural elasticity or by making the PICCor IV cavity slightly interfere with the catheter. The latter providesthe added benefit of keeping the secured devices fit snugly whencaptured. Around the snap hook area, the hook should first be formedwith a “shelf” feature which is then cut off, in order to maintain thehook's correct inner edge height.

FIG. 37F illustrates another embodiment of the locking mechanism. Thefront engagement 3781 generally has a generous draft of approximately 5to 15 degrees; this enables having a bigger undercut. This provides alead-in for snap 3781 that enables the snap to be designed with a deepengagement while still engaging easily. The cutout may cause the snaphook 3781 to weaken with the tendency to deform, therefore the areashould be adequately strengthened by ribs 3785 and 3790 as shown in FIG.37G. A pull tab 3789 can be added to aid releasing of the snap from thehook. The front edge 3786 and back edge 3788 of the snap receivercut-out 3787 should be on a flat surface to aid cutting. In other cases,a laser cutter may be used to create the cutout, in which case the facefrom which cut-out 3787 is created should slope outward by at least 3degrees or more to enable such lasercutting from a vertically mountedlasercutter. FIG. 37H shows a project or boss after forming and thenafter removing the cutout (for example by laser). FIGS. 37I-O showadditional locking mechanisms comprising snaps and hooks.

FIGS. 38A and B show catheter securement devices capable of securingflexible catheters of various sizes and diameters. In FIG. 38A, thesecurement device has a formed 3D component 3805 which is attached tothe adhesive holdfast 3807. Formed within formed 3D component 3805 is acentral pillar 3810 which can be of any shape but preferentially iscircular, around which a catheter is wound around using one or moreturns. Catheter inlet 3812 and catheter outlet 3814 are both seen.

FIGS. 38B-D show several views of the same catheter securement device.In 38B, the adhesive holdfast 3820 can be seen, attached to 3Dsecurement means 3840 which comprises a top securement door and bottomsecurement door (unlabeled) which are themselves connected via a livinghinge mechanism 3860 which allows each door to pivot relative to theother. A locking mechanism is seen, comprising a projection 3865 whichis formed from the bottom securement door and which fits within a cutoutwithin top securement door.

FIG. 38C shows the device of FIG. 38B, now in an open state, in whichthe top securement door 3842 and bottom securement door 3835 havepivoted apart. FIG. 38D shows a cross sectional view of the device inFIGS. 38B and C showing the top securement door 3842, bottom securementdoor 3835, adhesive holdfast 3820 and liner 3880. In operation, the userwould insert a flexible catheter, loop it around the central pillar3810, close the top securement door 3842 so that it locks itself intothe bottom securement door 3835 resulting in a audible “click” andtactile feedback, indicating the doors are locked and the cathetersecured. The liner may be removed (and the securement device applied tothe patient) either before or after the catheter has been placed intothe securement device.

FIG. 39 illustrates an alternative means to secure the catheter withinthe securement device, specifically showing an alternative to the use ofthe central pillar within a living hinge device. Viewed from the topdown, the catheter would be placed between one or more posts, and morepreferably three or more posts. After placement of the catheter, the topsecurement door would again be locked into the bottom securement door asdescribed previously in FIGS. 38B-D. FIG. 40 shows another means ofsecurement, showing an alternative means of securing a catheter usingseries of linearly placed or substantially linearly placed projectionsthat serve to receive a catheter and prevent its movement in anydirections. This approach may involve press fitting the catheter intothe projections without deforming the internal lumen of the catheter somuch so that flow of fluids is substantially compromised or reduced.

FIG. 4I shows another tube or catheter securement device in which aformed tube holder 4103 is attached by a double sided adhesive (notshown) to adhesive holdfast 4110. Formed tube holder 4103 has two ormore projections 4105 into which a tube or catheter is placed. Theadhesive wrap 4210 is then placed over tube holder 4103 and securedagainst the adhesive holdfast 4110, thereby securing the tube orcatheter onto the securement device and the patient's skin.

FIG. 42A-C and FIG. 43 show devices used to secure various sensorsincluding activity monitors and other health sensors to the body. FIG.42A shows a holder of an activity monitor from Fitbit. One of theimpediments to use of many activity monitors is that many people do notlike to have watches or other instruments wrapped around or tethered totheir wrist. The Fitbit One is an activity monitor that can be clippedonto the belt or other piece of clothing of the user.

The device shown in FIG. 42A provides another comfortable option toaffix the activity monitor to the user or his clothing etc. In FIG. 42A,a formed 3D cradle 4202 is adhesively secured to an adhesive holdfast4204. As shown in FIB. 42B, the activity monitor 4206 can then be placedonto the 3D cradle 4202. The liner is then be removed from the adhesivewrap 4206 and the adhesive warp affixed to the activity monitor, the 3Dcradle 4202 and/or the adhesive holdfast 4204 (and potentially the useror his clothing).

FIG. 42C shows another embodiment of an activity sensor. This embodimentshares similar features to other securement devices described herein,including the presence of a top securement door 4225, bottom securementdoor 4220 (on which the activity monitor sits), living hinge 4222,cutout 4245 and projection 4250. The rim 4235 that surrounds the bottomsecurement door 4220 is attached to the adhesive holdfast (not shown)using a double-sided adhesive. The operation of securement involves theuser placing the activity monitor onto the bottom securement door 4220,closing the top securement door 4225 relative to the bottom securementdoor 4220 until they are locked together (a click sound may be audible).The liner may then be removed and the securement device (which nowcontains the activity monitor) may then be placed on to the user of herclothing. Alternatively, the device may be placed first onto the user orher clothes and then the activity monitory placed and secured within thesecurement device. The user may place this or any of the activitymonitor securement device on any part of the body including the upperlimb, lower limb, abdomen, thorax, head, neck, or pelvis. Preferredlocations for placement include but are not limited to the wrist,forearm, or on the arm between the elbow and arm pit, including theinner or outer arm.

FIG. 42D shows another embodiment of an activity sensor securementdevice in which the activity monitor anchor 4300 surrounds and securesthe activity monitor (unlabeled). One or more apertures 4320 may bepresent on the top, side or any location of the activity monitor anchor,to provide access to oxygen (for the battery for example) or todissipate heat. A securement rim 4310 is attached to the activitymonitor anchor (4300) and itself is attached by adhesive (not shown) tothe adhesive holdfast 4350 which releasably secures the securementdevice (and activity monitor) to the user or her clothing.

FIG. 43 and FIG. 44 illustrate securement devices for the foley urinarycatheter and other catheters with a branching structure. FIG. 43 shows asecurement device that is “open”. The bottom securement door 4400 isformed as other 3D components already described herein. Within thebottom securement door 4400 is a depressed region designed to hold theurinary catheter 4410. The urinary catheter 4410 branches into tosmaller branches at branch point 4420 which is in close proximity tobranch securement point 4430. Also seen is a cutout 4470 and projection4460 which is located in the top securement door 4452. A living hinge4450 is also included.

FIG. 44 shows a device that operates similarly as the one in FIG. 43. Anadhesive holdfast 4485 is shown, onto which bottom securement door(unlabeled) is affixed. Ribs 4480 and living hinge 4490 are shown, alongwith top securement door 4475. This securement device is pictured in theclosed state and operates in a similar as other securement devicesdescribed herein that feature living hinges.

FIG. 45A illustrates a hook created using inline forming of 3D pieces, aprocess similar to other processes described herein. A circumferentialrib 4510 (which may be partially or incompletely circumferential in someembodiments) is shown, surrounding a center cutout area 4520. A hook4500 with hook ribs 4530 can also be seen. These ribs provide increasedstructural stability and durability to the hook. FIG. 45B shows avariant of the device shown in FIG. 45A in which the border (unlabeled)surrounding the entire hook device is raised. FIG. 45C shows theintermediate piece immediately after it has been formed in line. A lasercutter or die can be used to remove the cutout 4520 previously shown inFIG. 45A. The laser cutter will generally cut at an angle orthogonal tothe moving web of material/product. As mentioned above, the materialthat is removed (located between the hook 4500 and circumferential rib4510) is located on a gentle outwardly facing slope, with the lasercutter cutting out the excess material. In other words, face 4535 thatfrom which the cutout is formed has a slope that is less than vertical.This slope may be 1-5 degrees from vertical, from 5-10 degrees fromvertical, from 10-15 degrees from vertical, from 15-20 degrees fromvertical, from 20-25 degrees from vertical, from 25-30 degrees fromvertical, from 30-35 degrees from vertical, from 35-40 degrees fromvertical, from 40-45 degrees from vertical, from 45-50 degrees fromvertical, from 50-55 degrees from vertical, from 55-60 degrees fromvertical, from 60-65 degrees from vertical, from 65-70 degrees fromvertical, from 70-75 degrees from vertical, from 75-80 degrees fromvertical, from 80-85 degrees from vertical, or from 85-90 degrees fromvertical. The angle of the sloped faces may apply to any of the formed3D components and devices described herein.

FIG. 45D are hook devices of different sizes similar to those describedin FIGS. 45A-C. FIG. 45E illustrates another hook device that is held ona wall by an adhesive or magnet. Hooks like those shown in FIGS. A-E maybe used to store keys, Christmas lights or other objects. In some cases,a separate label slot may also be present in the product. FIG. 45Fillustrates the cross section of a hook device. Adhesive substrate 4570and formed layer 4580 are both shown.

FIG. 46A-C show a series of “J hooks. The formed 3D piece is seen inFIG. 46A. The top portion of the device called the fixation portion 4600attaches to the wall or other surface using an adhesive (not shown). Abend line 4605 can be seen, and may have a depressed or recessed portionthat allows movement (pivoting along the axis) between the fixationportion 4600 and the hook region 4610. As mentioned, there is anadhesive layer under part or all of fixation portion 4600. Below thebend line 4605, there is generally less or no adhesive layer. The hookregion is moveable. An optional “mouse hole cutout” can be seen as can astiffening rib 4615 that are present on the fixation portion 4600 and/orthe hook region 4610.

FIG. 46B shows a variant of the device seen in FIG. 46A. FIG. 46C showsanother variant of the device shown in FIG. 46A, designed to hold cordsor other objects.

FIG. 47 and FIG. 48 show other embodiments of devices that can be usedfor cord management or other purposes. Under the formed plastic pieces(and not shown) are the adhesive holdfast and/or liner. In some hookdevices, the adhesive holdfast may or may not have a foam substrate orother substrate layer. That is, the only components of the device may bea plastic 3D formed piece and a double sided adhesive with liner.

FIGS. 49 and 50 are cord organizers that have a formed portion that isbendable due to the presence of corrugations. FIG. 51 is anotherembodiment of a cord organizer. FIG. 52A is a top down version ofanother cord organizer/hook device with a cross section view shown inFIG. 52B.

FIG. 53 is a holder device with a formed receptacle 5300 which isadhesively attached to an adhesive substrate 5310 which is in turnadhesively attached to the wall or other object. In some cases such asFIG. 53B, the only components of such a device include a formedreceptacle 5300 and a double-sided adhesive (with removable liner) thatattaches the formed receptacle 5300 to the wall for example.

FIG. 54 is another hook device which uses a web converted 3D formedpiece along with a metal insert. An adhesive layer is present underneaththe 3D formed piece.

FIG. 55 is a hook device which has a formed 3D piece featuring a livinghinge. The flap portion of the device affixes to the wall using anadhesive layer. FIG. 56 is a variant of the device in FIG. 55 in whichthe adhesive layer is placed on the other side of the flap.

FIG. 57 is a cord organizer which uses a living hinge mechanism andlocking mechanism as described previously. FIG. 58 is another embodimentof a cord management device, again using a living hinge and lockingmechanisms.

FIG. 59 is another embodiment of a holder device in which the flap maybe adhesively secured to the wall or other location.

FIGS. 60A and 60B are embodiments of hooks which are manufactured usingprocesses that have been described herein.

FIG. 61 is a holder for paper or other planar or non-planar objects. Inthis case, there is a formed 3D anchor 6100, a hook 6130 and a cutoutregion 6120. This cutout region is cut from a formed, outwardly slopingwall, a process that has been described previously for other devices(including hooks) above. Also shown is an adhesive substrate 6110 whichis larger than the anchor 6100. In some cases, the outer diameter of theanchor 6100 will be the same as or larger than the outer diameter of theadhesive substrate. In some cases, the only components of the devicewill be the plastic formed piece, a double-sided adhesive and liner.

FIG. 62 shows a device comprising a series of small hooks 6200 on a rollof adhesive substrate 6210 with a liner 6220. These small hooks 6200 aremanufactured in an similar manner as other hooks described herein.

FIGS. 63-65 are simple clip devices designed to secure lightweightobjects such as paper or the like. They comprise a formed plastic piece,a double-sided adhesive and a liner. A rib can be seen in FIG. 63. Aswith other hook devices and other devices described previously, afterthe step of 3D forming, an intermediate form will have been created,with an outwardly sloping wall of plastic present between the top of thehook 6310 and the base of the hook 6320. The angle of this outwardlysloping wall will be similar to what has been described previously. Alaser cutter will then create the cutout, thereby creating the hook.

FIG. 66 is a self-adhesive holder that can be use as a business cardholder or could be used for other household or office purposes.

FIG. 67 illustrates a self-adhesive means of mounting small objects. Forexample, this could involve using such a device in a scrapbook.

FIG. 68 shows a corner mounting product which can be used to placephotographs in an album as one example.

FIG. 69 illustrates a nasogastric/orogastric tube securement devicewhich is designed to be more secure and easier to apply than currentmethods that utilize tape. An additional benefit is reduced adhesiveresidue after removal than current methods. Current nasogastric tubesare time consuming to painful to place and require x-rays to confirmlocation after placement. Thus an effective securement device thatprevents accidental dislodgement represents an improvement.

FIG. 70 illustrates an endotracheal tube securement device with anadhesive portion that attaches to both the patient's skin and the tube,as well as a formed plastic component designed to fit securely aroundthe tube, matched to the outer diameter of the tube (though in somecases it may be oversized or undersized).

FIG. 71 shows a pull tab which may be flat or may be formed into a 3Dconfiguration which is present between the adhesive and the skin for anyportion of the devices described herein. The tab (which does not haveadhesive between it and the skin) allows the user to easily beginremoval of the device. Further, the pulling of the tab in the directionof the skin helps remove the device with less pain and potentially lessresidue after removal. This tab may be planar in portions or formed intoa 3D shape in other portions. In many cases, the tab can be integratedinto other 3D formed portions of the device as has been previouslydescribed in the nasal strips described herein.

Method of Use

Conditions that may be treated with the subject device include but arenot limited to cuts, wounds, pressure ulcers, diabetic ulcers, burns,abrasions, surgical incisions, acne, psoriasis, allergic reactions, pain(including muscle pain, back pain and headache), cosmetic issuesincluding wrinkles, nail fungus, skin fungus and other conditions. Thedevices may be used to treat humans or animals.

As previously mentioned, any of the layered adhesive devices describedherein may be used to treat a variety of medical or non-medicalconditions. A subject may apply the device to his or her skin. Forexample, the devices may be first removed from clean or sterilepackaging. The devices described herein may be sized (e.g., child/adult,small, medium, large, etc.), or one-size-fits-all. Placement of anadhesive medical device may be done in front of a mirror or can occurwithout looking at a mirror, depending on the anatomic part of the bodyon which the device is being placed. A device having an adhesiveholdfast with a protective cover may be prepared for application byfirst removing the protective cover, and then aligning the device (oralignment guide in some cases) with the body part or part of the skinbeing treated. The device may then be applied by pushing the adhesiveholdfast against the skin or other body part to secure the device incommunication with the body. In some cases, it gauze or other tape maybe applied on top of the device and/or surrounding anatomic structures.After use, the device may be removed by peeling the adhesive holdfastaway from the body/skin.

With regard to devices that provide negative pressure wound therapy,there may be several steps followed: 1. Applying a wounddressing/absorbent material to the wound itself, with or without salineand/or antibiotics (Examples of this include cutting a polyurethane foamto the size of the wound and placing it onto the wound, putting it indirect contact with the wound surface). 2. Applying the plastic cap andintegrated dressing on the user's skin (on top of the wound). Theinitial absorbent material, plastic cap, and the area immediatelysurrounding the wound are now covered with an adhesive,fluid-and-air-tight cover film, such that a wound space is formedbetween cover film and wound base. The film adheres to the intact skinsurrounding the patient's wound and closes the wound space around theedges of the plastic cap in a gas tight manner. 3. Connecting the vacuumsource via the adapter or directly to the open end of exposed tubingstemming from the plastic cap. 4. Turning on, pumping, or otherwiseactivating the vacuum source. Initiating the negative pressure sourcegenerates a negative pressure in the wound space, i.e. in the spaceformed between the wound base and the plastic cap/double backedadhesive/hydrocolloid sealed top. 5. Turning off or otherwiseinactivating the vacuum source. 6. Unlocking or otherwise removing thereusable vacuum pump and affiliated tubing section from the rest of thedevice. 7. Removing and replacing the disposablehydrocolloid/cap/adhesive/tubing/ports section. 8. Reconnecting the twosections to each other, and reengaging the vacuum.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A method of making an adhesive support devicehaving a three-dimensional shape, the method comprising: placing aplanar sheet of material between a first tool and a second tool, whereinthe sheet of material extends in a first plane and wherein the materialhas an elastic modulus of greater than 0.4 GPa; stamping the planarsheet of material between the first tool and the second tool to deform aportion of the material so that it forms a cavity portion extending outof the first plane; securing an adhesive substrate to a base regionextending in the first plane wherein the base region is a portion of theplanar sheet peripheral to the cavity portion; and laser cutting one ormore walls of the cavity portion using a laser that is orientedperpendicular to the first plane.
 2. A method of making an adhesivesupport device having a three-dimensional shape, the method comprising:placing a planar sheet of material between a first tool and a secondtool, wherein the sheet of material extends in a first plane and whereinthe material has an elastic modulus of greater than 0.4 GPa; stampingthe planar sheet of material between the first tool and the second toolto deform a portion of the material so that it forms a cavity portionextending out of the first plane, wherein a wall of the cavity portioncomprises one or more ridges increasing the rigidity of the cavityportion; securing an adhesive substrate to a base region extending inthe first plane wherein the base region is a portion of the planar sheetperipheral to the cavity portion; and laser cutting one or more walls ofthe cavity portion using a laser that is oriented perpendicular to thefirst plane.
 3. The method of claim 2, wherein securing an adhesivesubstrate to the base region comprises securing the adhesive substrateso that the adhesive substrate is covered on a face opposite from thebase region by a liner.
 4. The method of claim 2, wherein a wallthickness of the cavity portion is less than an initial thickness of theplanar sheet of material, while the thickness of the base region isapproximately the same as the initial thickness.
 5. The method of claim2, wherein a ratio of a maximum length of the cavity portion in thefirst plane to a maximum depth of the cavity portion out of first planeis greater than 2:1.
 6. The method of claim 2, wherein the angles of allwalls of the cavity portion relative to adjacent portions of the baseregion extending in the first plane are greater than 90° and less than180°.
 7. The method of claim 2, further comprising cutting around thebase region to release the adhesive support device from the planar sheetof material.
 8. The method of claim 2, further comprising stamping theplanar sheet of material between a third tool and a fourth tool tofurther deform the cavity portion so that it extends further out of thefirst plane.
 9. The method of claim 2, wherein the method is performedwith the first and second tools at room temperature.
 10. The method ofclaim 2, wherein stamping the planar sheet of material between the firsttool and the second tool comprises compressing the planar sheet ofmaterial between complementary sides of a die, wherein the first toolforms an upper side of the die and the second tool forms lower side ofthe die.
 11. The method of claim 2, further comprising flattening thecavity region.
 12. The method of claim 2, wherein stamping comprisesforming a cavity region having a lattice pattern extending in parallelto the first plane to enhance stiffness.
 13. The method of claim 2,wherein placing comprises placing the planar sheet between projectingsurfaces of the first and second tool that have only rounded edges. 14.The method of claim 2, wherein stamping the planar sheet of materialbetween the first tool and the second tool to deform the materialcomprises stamping an elongate hinge region in the material, and furthercomprising forming a living hinge by folding the material along theelongate hinge region.
 15. The method of claim 2, further comprising diecutting one or more openings through the material.
 16. The method ofclaim 2, wherein the material comprises a polycarbonate, a polyethylene,or polyethylene terephthalate.
 17. A method of making an adhesivesupport device having a three-dimensional shape, the method comprising:placing a planar sheet of material between a first tool and a secondtool, wherein the sheet of material extends in a first plane and whereinthe material has an elastic modulus of greater than 0.4 GPa; stampingthe planar sheet of material between the first tool and the second toolto deform a portion of the material so that it forms a cavity portionextending out of the first plane, wherein a wall of the cavity portioncomprises one or more ridges increasing the rigidity of the cavityportion; stamping the planar sheet of material between a third tool anda fourth tool to further deform the cavity portion so that it extendsfurther out of the first plane; and securing an adhesive substrate to abase region extending in the first plane wherein the base region is aportion of the planar sheet peripheral to the cavity portion.
 18. Themethod of claim 17, wherein a wall thickness of the cavity portion isless than an initial thickness of the planar sheet of material, whilethe thickness of the base region is approximately the same as theinitial thickness.
 19. The method of claim 17, wherein a ratio of amaximum length of the cavity portion in the first plane to a maximumdepth of the cavity portion out of first plane is greater than 2:1. 20.The method of claim 17, wherein the angles of all walls of the cavityportion relative to adjacent portions of the base region extending inthe first plane are greater than 90° and less than 180°.
 21. The methodof claim 17, further comprising cutting around the base region torelease the adhesive support device from the planar sheet of material.22. The method of claim 17, wherein stamping the planar sheet ofmaterial between the first tool and the second tool comprisescompressing the planar sheet of material between complementary sides ofa die, wherein the first tool forms an upper side of the die and thesecond tool forms lower side of the die.
 23. The method of claim 17,further comprising flattening the cavity region.
 24. The method of claim17, wherein stamping comprises forming a cavity region having a latticepattern extending in parallel to the first plane to enhance stiffness.25. The method of claim 17, wherein placing comprises placing the planarsheet between projecting surfaces of the first and second tool that haveonly rounded edges.
 26. The method of claim 17, further comprising diecutting one or more openings through the material.
 27. The method ofclaim 17, wherein the material comprises a polycarbonate, apolyethylene, or polyethylene terephthalate.
 28. A method of making anadhesive support device having a three-dimensional shape, the methodcomprising: placing a planar sheet of material between a first tool anda second tool, wherein the sheet of material extends in a first planeand wherein the material has an elastic modulus of greater than 0.4 GPa;stamping the planar sheet of material between the first tool and thesecond tool to deform a portion of the material so that it forms acavity portion extending out of the first plane, wherein a wall of thecavity portion comprises one or more ridges increasing the rigidity ofthe cavity portion, wherein stamping the planar sheet of materialbetween the first tool and the second tool to deform the materialcomprises stamping an elongate hinge region in the material, and furthercomprising forming a living hinge by folding the material along theelongate hinge region; and securing an adhesive substrate to a baseregion extending in the first plane wherein the base region is a portionof the planar sheet peripheral to the cavity portion.
 29. The method ofclaim 28, wherein securing an adhesive substrate to the base regioncomprises securing the adhesive substrate so that the adhesive substrateis covered on a face opposite from the base region by a liner.
 30. Themethod of claim 28, wherein a wall thickness of the cavity portion isless than an initial thickness of the planar sheet of material, whilethe thickness of the base region is approximately the same as theinitial thickness.
 31. The method of claim 28, wherein a ratio of amaximum length of the cavity portion in the first plane to a maximumdepth of the cavity portion out of first plane is greater than 2:1. 32.The method of claim 28, wherein the angles of all walls of the cavityportion relative to adjacent portions of the base region extending inthe first plane are greater than 90° and less than 180°.
 33. The methodof claim 28, further comprising laser cutting one or more walls of thecavity portion using a laser that is oriented perpendicular to the firstplane.
 34. The method of claim 28, further comprising cutting around thebase region to release the adhesive support device from the planar sheetof material.
 35. The method of claim 28, wherein stamping the planarsheet of material between the first tool and the second tool comprisescompressing the planar sheet of material between complementary sides ofa die, wherein the first tool forms an upper side of the die and thesecond tool forms lower side of the die.
 36. The method of claim 28,further comprising flattening the cavity region.
 37. The method of claim28, wherein stamping comprises forming a cavity region having a latticepattern extending in parallel to the first plane to enhance stiffness.38. The method of claim 28, wherein placing comprises placing the planarsheet between projecting surfaces of the first and second tool that haveonly rounded edges.
 39. The method of claim 28, further comprising diecutting one or more openings through the material.
 40. The method ofclaim 28, wherein the material comprises a polycarbonate, apolyethylene, or polyethylene terephthalate.
 41. A method of making anadhesive support device having a three-dimensional shape, the methodcomprising: placing a planar sheet of material between a first tool anda second tool, wherein the sheet of material extends in a first planeand wherein the material has an elastic modulus of greater than 0.4 GPa;stamping the planar sheet of material between the first tool and thesecond tool to deform a portion of the material so that it forms acavity portion extending out of the first plane, wherein stamping theplanar sheet of material between the first tool and the second tool todeform the material comprises stamping an elongate hinge region in thematerial, and further comprising forming a living hinge by folding thematerial along the elongate hinge region; and securing an adhesivesubstrate to a base region extending in the first plane wherein the baseregion is a portion of the planar sheet peripheral to the cavityportion.